Frequently Asked Questions
Investigator Portal
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CONTENT
- What can I find in Investigator Portal?
Investigator Portal encompasses essential information on over:
• 292,000 bioactive compounds, including more than 274,000 with chemical structures
• 2,100 precedented therapeutic targets with pathway information
• 8,100 genomics records with gene-related studies and variants
• ? biomarkers records with uses/techniques
• 712 ,000 data values from experimental pharmacology studies that delineate drug/receptor and enzyme/target cell interactions
• 382,000 data values on pharmacokinetics/metabolism for parent compounds and active metabolites
• 89,000 references to clinical trials of compounds currently under study and/or in use in humans
• 104 disease briefings giving background references on diseases with full-color multimedia illustrations and web enhancements
• 907,000 references to the current literature, abstracts and proceedings from congresses and symposia and company communications
• 116,000 patent families from 11 leading sources.
- What are the information sources for Investigator Portal?
Principal information sources are the patent literature, biomedical literature and congresses, and company communications and Internet monitoring. Investigator Portal covers more than 1,500 journals and 400 conferences annually in the areas of medicinal chemistry, organic synthesis, experimental pharmacology, clinical pharmacology, biomarkers and genomics, as well as tracking the activity of 2,500 pharmaceutical and biotechnology companies.
- How far back does the information in Investigator Portal go?
The focus of Investigator Portal is on products in discovery or development since 1988. The information in the Drugs & Biologics, Patents and Literature Knowledge Areas dates back to 1988, with more than 1,500 selected back records added for specific compounds (e.g., aspirin). Information in the other Knowledge Areas dates back to the late 1990s in some cases (Experimental Pharmacology), the year 2000 (Clinical Studies, Disease Briefings), the year 2001 (Targets & Pathways, Genomics) and the year 2007 (Biomarkers), with selected back records entered.
- What is the lag time for the incorporation of patent data into Investigator Portal?
WO, EP and US patent citations are available 24 hours after publication, and JP patent citations are available within 5 days of publication. Patents are fully analyzed with the inclusion of added value chemistry and pharmacology within 1–2 weeks following their inclusion in our system. The time for literature and congress records to be included is usually 0–2 weeks (from the date the information is first made available to incorporation).
REGISTRATION & LOGIN
- How do I log on to Investigator Portal?
Go to www.investigatorportal.com. Once your institution has subscribed to Investigator Portal, you will have fully access to all areas. The first time you enter, you should click ‘First Time Users’, you will be promted to fill in a short registration form and choose your own User Name and Password. Make a note of your chosen User Name and Password. Registration is immediate and you can now you can log on anytime by entering your newly created User Name and Password and clicking Login.
- Can I self-register?
You can self-register for Investigator Portal only if your institution has licensed access. If you are not sure, contact your library and send an email to ivpsupport@prous.com.
- Will my Investigator Portal access work ‘Off Campus’?
Access authentication is by institutional IP address so you will only be able to login when using a computer at one of the official institution sites.
- Can I share my password with a colleague?
Investigator Portal user names and passwords are personal and nontransferable under the Investigator Portal Terms of Use. A user name/password combination defines an individual user account in Investigator Portal, and each account may have a single e-mail address entered for receiving Alerts. Sharing a user name/password combination violates the confidentiality of the original user's Saved Queries and Alerts and prevents the other user from using the Alert feature. If two users attempt to use a user name/password combination simultaneously, they will be ejected from the system.
DEFINITIONS & ABBREVIATIONS
- What is a drug ‘Under Active Development’?
The Under Active Development label appears on records for products that are actively moving through the drug R&D pipeline from preclinical stages through registration (i.e., preclinical, IND filed, phase I, phase I/II, phase II, phase II/III, phase III, preregistered, recommended approval and registered).
The criteria for labeling a compound Under Active Development include the following, which must have occurred over the most recent 12 months:
a) the company is actively informing the public on the development of the product via press releases, mention in annual reports, citation on the company's website (particularly, if the company publishes a "pipeline" and the product is included in it, and/or:
b) references to the compound that indicate its progress are being published in the biomedical literature (journals and congresses).
The Under Active Development Checkbox term can be used to refine your results to retrieve only those compounds that are under active development or not under active development.
Under Active Development is indicated in the Full Product Record. The Entry Numbers of UAD products appear in red and are marked with an asterisk. The products not under active development appear in blue.
- What is a Prous Entry Number (EN)?
The Prous Science Entry Number is a 6-digit compound ID number assigned to every bioactive compound found in the Prous Science database. It serves as a compound identifier throughout a drug’s life. Prous Science ENs are assigned sequentially. 5-digit ENs are for drugs added retrospectively.
- What is a New Molecular Entity (NME)?
A new molecular entity in Investigator Portal is a compound described for the first time in the biomedical literature, at a congress or in a company communication that is identified by an investigational code or chemical name. The NME status is retained for 4 months.
- What is a Product Summary Report?
The Drugs & Biologics Knowledge Area is enhanced with the addition of a Product Summary Report feature that facilitates presentation of key product information in an attractive report form.
- What are Targetscapes?
Molecular landscapes illustrating the interaction between the key targets in the pathological state with hyperlinks to the specific target records. These are available from the therapeutic target full records and are standardized across different diseases.
- What do Validated and Candidate mean when associated with conditions in Target records?
An algorithm is used to give an indication of how valid a target is for a condition by putting the label validated if a product acting on the target and associated with the condition has been tagged Under Active Development and has reached clinical testing phase. A candidate target is defined as one where a drug acting on that target and associated with the condition has been tagged Under Active Development has reached preclinical (animal) testing phase.
- How are the validities defined in Biomarkers?
These indicate how far advanced specific techniques are for a particular role (use). Experimental is the least advanced level and is similar to Biological Testing in D&B. Under testing is the intermediate level. Recommended/Approved is the most advanced level and and requires and well renowned medical society or regulatory agency to recommend its use in a guideline or position statement.
- What are Disease Monographs?
Dynamic executive summaries on the current status and future trends in drug therapy for specific diseases. These include background information on the disease, history, etiology and epidemiology, causes and risk factors, diagnostic techniques, treatment options and future research trends. Compounds currently used to treat the disease and those under study are listed with hyperlinks to the drugs and biologics section for further information on the compound, as well as links to related information and websites.
- What is the difference between Phase and Highest Phase?
Highest Phase indicates the highest phase that a product has reached for any condition and is found in the Full Product Record near the top left-hand side of the page. Each compound has only one highest phase whereas it can have multiple Phases. Phase is found in the full Development Status Table (accessed by clicking the Details button at the top of the Development Status Summary in the Full Product Record). This table contains recorded highest phases for specific conditions, territories and organizations.
- How does the Mechanism of Action search field work in Investigator Portal?
The Mechanism of Action field utilizes a controlled vocabulary that describes the various types of mechanisms of action for bioactive compounds — for example, Angiotensin-l Converting Enzyme (ACE) Inhibitors, Calcium Channel Blockers, Angiotensin Receptor Antagonists, Dopamine D1 Agonists, etc. The Mechanism of Action search field is useful for retrieving very specific groups of compounds that work by the same mechanism. It can also be used with the Boolean operator AND to search for compounds with a dual mechanism of action — such a search example would "Angiotensin-I Converting Enzyme (ACE) Inhibitors" AND "Neprilysin (Enkephalinase, Neutral Endopeptidase, NEP) Inhibitors". The Browse Index for the Mechanism of Action search field provides a highly targeted approach to selecting search terminology for use in accordance with a hierarchical scheme. This search field can also be used to select terms from an alphabetic list or users can use the pre-search field (Lookup box) to create a short list of potential search terms.
- What are the definitions for the Development Phase terminology in Investigator Portal?
Biological Testing : Products from patents are entered into this phase. Preliminary pharmacology (in vitro testing) data may be available.
Preclinical : In vivo testing; testing in animals has started.
IND Filed : Application has been filed with the competent authority requesting permission to test the drug in humans ( IND = Investigational New Drug Application in U.S.).
Clinical : Used when it is known that the drug is in clinical testing, but the exact phase is not known.
Phase 0 : an FDA approved trial which tests small quantities of experimental drugs on humans.
Phase I : Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness have started; usually conducted in healthy volunteers.
Phase I/II : Studies that combine certain aspects of phase I trials and phase II trials: example, a safety study in patients.
Phase II : Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks have started.
Phase II/III : Studies that combine certain aspects of phase II trials and phase III trials.
Phase III : Expanded controlled and uncontrolled trials have started after preliminary evidence suggesting effectiveness of the drug has been obtained. These are intended to gather additional information to evaluate the overall relationship of the drug and provide an adequate basis for physician labeling benefit-risk.
Pre-registered : Application to market the drug (e.g., New Drug Application or Marketing Authorisation Application) has been filed.
Recommended Approval : Approval of the drug has been recommended by the corresponding FDA Advisory Committee or a Positive Opinion has been issued by the CHMP.
Registered : The competent regulatory authority has approved the drug for marketing, but the drug is not yet available on the market.
Launched : The drug is being marketed.
Discontinued : Development of the product has stopped before a registration dossier has been filed.
Suspended : The product is stopped when undergoing regulatory review.
Withdrawn : The product is withdrawn from the market after launch.
Undetermined : Development status is unknown.
Not Applicable : A preparation or extract that is under study as a drug is also possibly (or definitely) already available on the market as an unregulated health food supplement.
- What are the definitions for the Milestones terminology in Investigator Portal?
Abbreviated New Drug Application (ANDA): (Only applicable for the U.S. Food and Drug Administration). Contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs (ANDA Filed), provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Once approved (ANDA Approved), an applicant may manufacture and market the generic drug product to provide a safe, effective, low-cost alternative.
Acquired: A product is acquired by a new company, usually by acquisition/merger with another company.
Application withdrawn: An application for approval (NDA filed, sNDA filed, BLA filed, sBLA filed, ANDA filed in US; MAA filed in EU; pre-registered in other countries) is withdrawn when the Company is unable to satisfy the Administration requirements. If an applicant withdraws an original application for approval or supplement before FDA has completed its review, the review clock stops on the date FDA receives the letter notifying it of the withdrawal. As an example, if new data are required by the Administration before giving the approval and the Company is unable to perform the trials in time, it withdraws the application and resubmits it later with the entirety of data available.
Approvable Letter: (Only applicable for the U.S. Food and Drug Administration).
An official communication from FDA to an application for approval sponsor that allows the commercial marketing of the product. An approvable letter informs the applicant that FDA has completed the scientific review of its application for approval and determined that it can be approved pending resolution of minor deficiencies identified in the letter or during FDA's inspection of the device's manufacturing facilities.
Biologic License Application (BLA): (Only applicable for the U.S. Food and Drug Administration).
Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product. A biologic license application is a submission (BLA filed) that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved (BLA Approved) and a license is issued allowing the firm to market the product.
Codeveloped: A product which is being developed by more than one company.
Clinical Trial Authorization (CTA) filed: (Only applicable for the E.U. European Medicines Agency - EMEA). Application for authorization for the beginning of a clinical trial.
Fast Track Designation: (Only applicable for the U.S. Food and Drug Administration).
A designation that the US Food and Drug Administration (FDA) reserves for products intended to treat a serious or life threatening condition, and that have the potential to address an unmet medical need. The FDA takes appropriate actions to expedite the development and review of the approval applications for fast track products. The Fast Track program enables a company to file an NDA on a rolling basis as data becomes available. This permits the FDA to review the filing as it is received, rather than waiting for the entire document prior to commencing the review process. With a Fast Track designation, there is an
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opportunity for more frequent interactions with the FDA and possibility of a priority review, which could decrease the length of a typical review period.
Investigational Device Exemption (IDE) filed: (Only applicable for the US Food and Drug Administration). An application for authorization for an investigational device to be used in a clinical study in order to collect safety and efficacy data required to support a Premarket Approval Application (PMA).
Investigational New Drug ( IND) filed: (Only applicable for the US Food and Drug Administration).
An application for authorization for a drug product to be used in a clinical study in order to collect safety and efficacy data required to support a New Drug Application (NDA).
Licensed: A company licenses a drug when it sells all or part of the rights it holds from the drug to another company. As an example, the owner company can just sell rights for a certain condition or for development and/or marketing in certain countries, only.
Licensee agreement terminated: When a previous license agreement has expired or has been cancelled.
Marketing Authorization Application (MAA): (Only applicable for the E.U. European Medicines Agency - EMEA). MAA filed is the submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets EMEA requirements, the application is approved (MAA Approved) and a license is issued allowing the firm to market the product.
New Drug Application (NDA): (Only applicable for the U.S. Food and Drug Administration).
When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits to FDA a new drug application (NDA Filed). The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved (NDA Approved), the product may be marketed in the United States.
Negative Opinion: (Only applicable for the E.U. European Medicines Agency — EMEA).
The Committee for Medicinal Products for Human Use (CHMP) of the EMEA is responsible for preparing the Agency's opinions on all questions concerning medicinal products for human use. In the “Community” or “centralized” procedure, the CHMP is responsible for conducting the initial assessment of medicinal products for which a Community-wide marketing authorization is sought. If CHMP considers that the medicinal product is not approvable, it gives a Negative Opinion.
Not Approvable Letter: (Only applicable for the U.S. Food and Drug Administration).
A not approvable letter informs the PMA applicant that FDA has completed the scientific review of the PMA and does not believe that the PMA can be approved because of the significant deficiencies identified in the letter. After the applicant receives a not approvable letter, he or she may: amend the PMA to address the deficiencies; withdraw the PMA; or consider this letter to be a denial of approval of the application.
For original applications, a not approvable letter is issued after FDA has conducted a complete review of the application, including any recommendations by an FDA advisory panel, if applicable, and determines that the available data in the application do not support a determination of reasonable assurance of safety and effectiveness. Generally, before FDA issues a not approvable letter, the agency provides the applicant with an opportunity to address its concerns through a major deficiency letter.
Not Recommended Approval: (Only applicable for the U.S. Food and Drug Administration).
In some cases, FDA seeks the recommendations of advisory committees made up of outside experts. These expert advisers add to FDA's understanding, so that final agency decisions will more likely reflect a balanced evaluation. Committee recommendations are not binding on FDA, but the agency considers them carefully when deciding drug issues. Not Recommended Approval means that the advisory committee considers that the drug is not approvable.
On Hold: A product development is placed temporarily on hold by the company, usually as a voluntary measure. As an example, if the Data Monitoring Committee (DMC) has requested additional data, if protocol revisions are needed, etc.
Orphan Drug Designation: There are many diseases and conditions which affect such small numbers of individuals that are considered rare and adequate drugs for many of such diseases and conditions have not been developed. Drugs for these diseases and conditions are commonly referred to as "orphan drugs". It is in the public interest to provide incentives for the development of orphan drugs. In the EU, the term “Orphan Drug” refers to a product that treats a serious or life-threatening disease that affects fewer than five people per 10,000 population. In the US, the term “Orphan Drug” refers to a product that treats a disease that affects fewer than 200,000 people in the country. Orphan drug designation may qualify recipients for exclusive marketing rights in the United States for seven years and in the EU for ten years if the company is first to receive marketing approval for this product.
Outlicensing: A product which is available for licensing.
Premarket Approval Application (PMA): (Only applicable for the U.S. Food and Drug Administration). Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of Class III devices. A Class III device is defined as one that supports or sustains human life or is of substantial importance in preventing impairment of human health or presents a potential, unreasonable risk of illness or injury. The applicant submits to FDA a PMA (PMA filed). If the license is granted (PMA approved), the applicant is authorised for marketing a particular medical device.
Positive Opinion: (Only applicable for the EU European Medicines Agency — EMEA).
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The Committee for Medicinal Products for Human Use (CHMP) of the EMEA is responsible for preparing the Agency's opinions on all questions concerning medicinal products for human use. In the “Community” or “centralized” procedure, the CHMP is responsible for conducting the initial assessment of medicinal products for which a Community-wide marketing authorization is sought. If CHMP considers that the medicinal product is approvable, it gives a Positive Opinion.
Recommended Approval: (Only applicable for the U.S. Food and Drug Administration).
In some cases, FDA seeks the recommendations of advisory committees made up of outside experts. These expert advisers add to FDA's understanding, so that final agency decisions will more likely reflect a balanced evaluation. Committee recommendations are not binding on FDA, but the agency considers them carefully when deciding drug issues. Recommended Approval means that the advisory committee considers that the drug is approvable.
Supplemental Biologic License Application (sBLA): (Only applicable for the U.S. Food and Drug Administration). A supplemental biologic license application submission (sBLA filed) is required by the FDA for biologic products when changes are made in the manufacturing processes or label, for the marketing authorization of a new formulation, strength or indication. If the information provided meets FDA requirements, the application is approved (sBLA Approved).
Supplemental New Drug Application (sNDA): (Only applicable for the U.S. Food and Drug Administration). A supplemental new drug application submission (sNDA filed) is required by the FDA when changes are made in the manufacturing processes or label of a drug, and for the marketing authorization of a new formulation, strength or indication. If the information provided meets FDA requirements, the application is approved (sNDA Approved).
Suspended: A trial is suspended (enrollment or patients treatments) usually following thefety Monitoring Board (DSMB). The company temporarily suspends a trial as a precaution when adverse events are detected, new data are required, etc. recommendation of a Data Safety Monitoring Board (DSMB). The company temporarily suspends a trial as a precaution when adverse events are detected, new data are required, etc.
- What abbreviations are used for techniques in Biomarkers?
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·CCA — Circulating Anodic and Cathodic Antigen Assay
·CEC — Capillary Electrochromatography
·CTC Epithelial — Circulating Tumor Cells Epithelial
·CE-SSCP — Capillary Electrophoresis Single Strand Conformational Polymorphism
·DHPLC — Denaturing High-Performance Liquid Chromatography
·DMEGS — Dynamic Multiple Equilibrium Gradients
·EAA — Excitatory Amino Acid
·ECG — Electrocardiogram
·eTAG — eTag Assay
·GWAS — Genome-Wide Association Study
·HPLC — High-performance liquid chromatography
·IHC — Immunohistochemistry
·CLISA — Cluster-Linked Immunosorbent Assay
·ECLIA — Electrochemiluminescence Immunoassay
·EIA — Enzyme Immunoassay
·ELFA — Enzyme-Linked Gluorescence Assay
·ELISA — Enzyme-Linked ImmunoSorbent Assay
·IA — Immunoassay
·IRMA — Immunoradiometric Assay
·RIA — Radioimmunoassay
·CISH — Chromogenic in situ Hybridization
·FISH — Flourescence in situ Hybridization
·mRNA ISH — Multiplex Fluorescent mRNA in situ Hybridization
·SISH — Automated Silver Enhanced in situ Hybridisation
·LCR — Ligase Chain Reaction assay
·DCC Binding Assay — Dextran-coated Charcoal Binding Assay
·CIM — Cell Migration and Invasion Assay
·MIDIA — Microfluidic Deletion/Insertion Analysis
·MLPA — Multiplex Ligation-dependent Probe amplification
·AS-PCR — Allele Specific Polymerase Chain Reaction Assay
·LCR+Seq — Ligase Chain Reaction and Sequential Assay
·LDI-PCR — Laser Doppler Perfusion Imaging — Polymerase Chain Reaction Assay
·Methylation PCR — Methylation Polymerase Chain Reaction
·PCR + DirectSeq — Polymerase Chain Reaction and DirectSeq
·PCR MSI — Polymerase Chain Reaction Microsatellite instability Assay
·PCR SSCP — Polymerase Chain Reaction Single Strand Conformation Polymorphism Assay
·PCR/LOH — Polymerase Chain Reaction / Loss of Heterozygosity
·PCR-RFLP — Polymerase Chain Reaction — Restriction Fragment Length Polymorphism Assay
·PNA-PCR — Peptide Nucleic Acids — Polymerase Chain Reaction Assay
·RQ-PCR — Real Time Quantitative Polymerase Chain Reaction Assay
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·RT-PCR — Reverse Transcription Polymerase Chain Reaction
·PTT — Partial Thromboplastin Time
·SPECT — Single Photon Emission Computed Tomography
·TRAP — Telomere Repeat Amplification Protocol Assay
- What abbreviations are used for parameters in Experimental Pharmacology?
-
• CC — Cytotoxicity
• EC — Effective Concentration
• ED — Effective Dose
• IC — Inhibitory Concentration
• Kb — Equilibrium Dissociation Constant for an antagonist
• Kd — Equilibrium Dissociation Constant
• Ki — Affinity/Inhibitory Constant
• Ki(h) — Affinity/Inhibitory Constant (high affinity component)
• Ki(l) — Affinity/Inhibitory Constant (low affinity component)
• LD — Lethal Dose
• MBC — Minimum bactericidal concentration
• MCC— Minimum cytotoxic concentration
• MEC — Minimum effective concentration
• MED — Minimum effective dose
• MFC — Minimum Fungicidal Concentration
• MIC — Minimum Inhibitory Concentration
• MID — Maximum Inactive Dose
• MLD -Minimum Lethal Dose
• MPC— Mutation Prevention Concentration
• MTD — Minimum Tolerated Dose
• MUD — Minimum Ulcerogenic Dose
• NTD — Non-toxic Dose
• UD — Ulcerogenic Dose
• pA-2 -Antagonism Constant
Modifier used is p to indicate the log form
- What abbreviations are used for parameters in the Pharmacokinetics/Metabolism Knowledge Area?
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• AUC (A-B) — Area under curve for a given interval from time A to time B in hours
• BR (A-B) — Biliary recovery between time A and time B (in hours).
• Cl — Clearance; the rate of elimination by all routes ( or by specified route(s) and mechanism(s) of elimination, as indicated by a letter in parenthesis
• Cl(B) — Biliary clearance
• Cl(H) — Hepatic clearance
• Cl(R) — Renal clearance
• Cl(XR) — Extra-renal clearance
• Cmax — Peak concentration
• Cmin — Trough concentration
• Css — Average plasma concentration of an administered drug at steady state.
• ER (A-B) — Recovery in exhaled air from time A to time B (in hours)
• F — Bioavailability
• FR (A-B) — Fecal Recovery between time A and time B (in hours)
• ka — Absorption constant
• kel — Elimination rate constant
• MAT — Mean Adsorption Time
• MR — Milk Recovery
• MRT — Mean Retention Time
• PB — Protein Binding
• Q — Intercompartmental clearance
• t1/2 — Half-life
• tlag — Lag time
• Tmax — Time to peak concentration
• Tss — Time to steady state
• UR (A-B) — Urinary Recovery from time A to time B (in hours).
• Vd — Volume of distribution
• Vd(c) — Central volume of distribution
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• Vd(p) — Peripheral volume of distribution
• Vss — Volume of distribution steady state
• Vss(c) — Central volume of distribution steady state
• Vss(p) — Peripheral volume of distribution steady state
• Vss(e) — The proportionality constant that relates the amount of drug in the body to the serum concentration under steady state conditions in the elimination phase
- What modifiers are used for parameters in the Pharmacokinetics / Metabolism Knowledge Area?
-
• (A-B): Time A to Time B in hours
• _b: bound drug
• _t: total (drug plus metabolite)
• _u: unbound drug
• _p: parent drug (excluding metabolites)
• (c): central
• (p): peripheral
• (e): elimination phase
• (B): biliary
• (H): hepatic
• (R): renal
• (XR): extrarenal
- What abbreviations are used for administration route in the PK/Metabolism Knowledge Area?
• bucc.: buccal
• e.d.: epidural
• i.a.: intraarterial
• i.art.: intraarticular
• i.b.: intrabiliar (bile duct cannulation)
• i.car.: intracardiac
• i.col.: intracolonic
• i.cor.: intracoronary
• i.c.v.: intracerebroventricular
• i.d.: intraduodenal
• i.g.: intragastric
• i.i.: intraileal
• i.int.: intraintstinal
• i.j.: intrajejunal
• i.m.: intramuscular
• i.n.: intranasal
• i.o.: intraocular
• i.otic: intraotic
• i.p.: intraperitoneal
• i.p.v.: intra portal vein
• i.str: intrastriatal
• i.t.: intratracheal
• i.thec.: intrathecal
• i.tymp: intratympanic
• i.uter: intrauterin
• i.v.: intravenous
• i.vag: intravaginal
• i.ves.inst.: intravessical instillation
• i.vitr. : intravitreous
• infiltr.: infiltration
• inhal.: inhaled
• p.o.: per os; oral
• pharing: oro-pharingeal
• rect.: rectally
• rinse: mouth rinse
• s.c.: subcutaneous
• s.conj.: subconjuntiva
• s.gin.: subgingivally
• s.l.: sublingual
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• top.: topical
- What abbreviations are used for dosage in the PK/Metabolism Knowledge Area?
-
• b.i.d.: (twice daily)
• o.d.: (once daily)
• s.d.: (single dose)
• t.i.d.: (three times daily)
• q.i.d.: (four times daily)
The remaining dosage abbreviations utilized tend to follow a pattern as per below:
o.d. x 3d = once daily for 3 days
1x/3 wks x 2h = once every three weeks for two hours
SEARCHING
- What are the methods for obtaining data from Investigator Portal?
There are four ways of searching in Investigator Portal:
• Quick Search
• Guided Search
• Quick Access Links (e.g. Latest news)
• Disease Briefings (searching based on a medical condition or disease)
- How does Quick Search work?
This is a feature to see at a glance the information available in all Knowledge Areas of Investigator Portal. The Quick Search searches across the most relevant text-based fields in each Knowledge Area. It does not search across date fields or Y/N fields. Do not use hyphens or apostrophes in search terms; instead, use an asterisk as a substitute for one or more characters. An asterisk can also be used as a truncation indicator on either the left or the right. When entering a company code drug name, omit the hyphen: Ex: FK506.
- How does the Guided Search work?
This feature is used when the user is not sure of the term needed to search Investigator Portal or when a user wants to conduct a more specific search. There are conreolled vocabularies for 6 of the sections in the guided search. The user can open a controlled vocabulary and open the ‘+ sign’ hierarchies to find the required search term or alternatively input the first few letters into the ‘Lookup’ box and click enter. The system then open the hieracrchy at the first point at which those letters are found and the user should use ‘Next>’ to move on to the term required.
Where more than one term is selected within one field, Investigator Portal uses the boolean ‘OR’ operator but this can be manually changed to ‘AND’ by the user.
The user can restrict the search by knowledge area, e.g. searching EGFR as a genomic record rather than a biomarker or therapeutic target.
- What are the Quick Access Links?
These are links found on the Investigator Portal home page and these include:
• Today’s News: Links to the 4 most significant news items entered in the last 24 hours
• Congresses: Links to selected references from recent conferences
- How do I know when to search in Targets & Pathways and when to search in Genomics?
Targets & Pathways contains information on precedented targets with separate gene and protein records. It has links and information on associated products. A gene record in Targets & Pathways will always have an associated Genomics record. Genomics has combined gene a protein records and contains information on gene-related studies. There are no links between the genomics record and products.
DATA MANAGEMENT
- Is it possible to export records?
This is an enhancement that we expect to include in early 2009. Users will be able to export records to Excel format. Each export operation will export a maximum of 100 records at one time.
- Can chemical structures be exported?
No.
- Is structure/sub-structure searchin possible?
This feature is not available at present.
CUSTOMER SUPPORT
- How do I contact Thomson Reuters for technical support or content questions?
Send questions, comments and suggestions to Investigator Portal Support by completing and sending the Help Request Form found under Support/Help or by e-mailing:
IVPsupport@prous.comMany new features included in Investigator Portal are developed in direct response to suggestions received from end users and users are therefore encouraged to send suggestions for enhancements to IVPsupport@prous.com
BIOMARKERS
- What can I find in the Biomarkers Knowledge Area?
The Biomarkers Knowledge Area covers well-established and Biomarkers under study from all stages of research in six main therapeutic areas: oncology, cardiovascular disease, diabetes, immunology, respiratory diseases and neurological disorders. By the end of 2008 we will have comprehensive coverage of all reported biomarkers in these therapeutic areas. From 2009 onward we will extend coverage to all biomarkers irrespective of discipline.
The database covers a variety of types of biomarkers, including proteomic, genomic, biochemical, cellular and physiological (see the ;DEFINITIONS & ABBREVIATIONS section of this document). A biomarker can have a number of ‘uses’. Whenever there is sufficient, reliable evidence in source documents to support a use, it will be indexed within a Biomarkers full record.
- What is the standard of selection to include a biomarker in Investigator Portal?
There must be reliable scientific evidence in a published source to support a specific use of a biomarker. The minimum content for addition to the database is biomarker name and at least one use. Each use must be associated with a disease, adverse effect or underlying disease pathology and must have a role (diagnosis, prognosis etc).
- Why do I see indications outside the six current therapeutic areas in the database?
Biomarkers are not necessarily exclusive to one therapeutic area. They may be related to biological processes that are involved in many different diseases.
When a biomarker is added to the database, information on all uses is added whether or not these fall within the six main areas.
- How often and what sort of changes are made to the biomarker Knowledge Area?
The database is updated on a daily basis. Our tracking of information sources not only looks for content on biomarkers not yet entered in the database, but also for new or updated information on biomarkers for which there is an existing record. This could be:
• a new use under study (a use is a combination of indication, population, role and technique)
• information indicating that the use has advanced (for example, gone from experimental use to use in humans, akin to a phase change for a drug)
• a relevant new reference to add to the database, albeit one that doesn’t prompt a change in a lifecycle status for the biomarker (or information on a new kit in development, as another example).
- What is the quality assurance process for data entered into the Biomarkers Knowledge Area?
The database is curated by scientists who read the information found in the references, analyze this information and prepare the full record, including the information on the biomarker itself and its uses, as well as on the development of any kits associated with a use (depending on the biomarker’s lifecycle stage, of course). They are supported by modern, computerized tools to locate literature and patent references and to process the information. All records must pass through a rigorous quality control process before being released into the database. The quality control team is independent of the editorial team and consists of people educated to at least PhD level. Members of the quality control team, with specific expertise, check individual fields of a record. Then the entire record is checked to ensure all the information is internally consistent.
- What are the information sources for the Biomarkers content?
Principal information sources are biomedical literature and congresses, clinicaltrials.gov, the FDA website and patent literature ( WO, US, EP and JP). Work is underway to expand coverage to include press releases and other information from company websites. The main sources are:
• Scientific meetings: Information is taken from meetings that specialize in biomarkers content (such as World Biomarkers Summit) as well as relevant meetings in all therapeutic areas where data related to biomarkers can also be presented (ASCO, ACCR, ADA, AUA, etc)
• Literature Information: References are identified by searching MEDLINE® and full-text of peer reviewed journals included in the Web of Science. Guidelines from scientific societies are usually included here.
• Patents: From four patent authorities: Japan Patent Office (JP), World Intellectual Property Organization (WIPO), US Patents & Trademark Office (US) and European Patent Office (EP).
- How far back does the information go in the Biomarkers Knowledge Area?
When a biomarker is identified and selected for inclusion in the Biomarkers Knowledge Area, the editorial analysts search literature from the last five years and clinical guidelines from the previous 10 years. Due to the fast rate of biomarker research, if a biomarker is relevant, it will be mentioned in papers published during the last five years. Guidelines can be current but not necessarily recently updated, hence the search is expanded to track older (but still current) guidelines.
- Where do the Synonyms in a Biomarkers full record come from?
Synonyms are taken from the NCBI, Uniprot, MeSH® terms and Expasy database.
- How is a biological process term assigned to a Biomarkers Knowledge Area record?
When an editorial analyst finds evidence in a source document to support a link between a biomarker and a particular biological process, the process is indexed. The most appropriate (usually the most specific but always the most descriptive) term from the Gene Ontology Consortium list is intellectually assigned based on information in the source.
- What are the criteria to link a drug to a Biomarker full record?
A launched drug or biologic is linked to a biomarker when the drug is specifically mentioned in a clinical guideline, or the FDA approval letter states that it is a targeted therapy using a named drug.
- What are the criteria for including diagnostic kits in Biomarkers?
Kits are included when there is an FDA approval letter.
- What are the criteria for linking an organization to a Biomarkers record?
Companies are linked to a biomarker record if they make a kit for which an FDA approval letter has been identified by our editorial analysts.
- How are validities (lifecycles phases) defined in the Biomarkers Knowledge Area?
Recommended/approved: Kit or measuring device/software is approved by the FDA or other government authority, and/or the use of the biomarker is described in clinical practice guidelines or consensus development statements have been issued by clinical societies of international standing.
Late studies in humans: The biomarker use has been studied in humans (clinical trials and observational studies) but has not yet been approved by a regulatory authority. Should be studies with over 500 individuals. The objective is to measure efficacy and to establish the relationship found in early studies in humans.
Early Studies in Humans: The biomarker use has been studied in humans (clinical trials and observational studies). Should be studies with less than 500 individuals. The objective of these studies is to measure proof of concept and dose finding.
Experimental: Reports from preclinical studies (laboratory and/or animal studies).
Discontinued: For a biomarker use that is not “Recommended/approved” for which no data has been reported in 12 months.
- How are validities (lifecycles phases) assigned in Biomarkers Knowledge Area?
The highest validity corresponding to each use of a biomarker has to be assigned. This means if a use is reported in papers with results from clinical trials in different phases but the same use is described in a clinical practice guideline, the use will be assigned the validity status “Recommended/approved”.
- What are the definitions for roles in Biomarkers Knowledge Area?
Diagnosis: The role of this biomarker is to identify or detect a disease.
Differential Diagnosis: The role of this biomarker is to distinguish between two or more diseases with similar signs and symptoms.
Monitoring Treatment Efficacy: The role of this biomarker is to identify signs of a change (usually beneficial) as a result of treatment. A biomarker used for monitoring treatment efficacy is usually measured before the treatment starts (baseline) and at stages throughout the treatment (follow up).
Monitoring Treatment Toxicity: The role of this biomarker is to identify signs of adverse effects as a result of treatment. Measured at baseline and at stages throughout treatment.
Prediction of Drug Resistance: The role of this biomarker is to detect possible resistance to a therapy and thus to exclude that therapy from the possible therapies available to the patient.
Predicting Treatment Efficacy: The role of this biomarker is to predict a probable beneficial outcome as a result of treatment.
Predicting Treatment Toxicity: The role of this biomarker is to predict a probable adverse effect as a result of treatment.
Prognosis: The role of this biomarker is to predict the probable outcome of a disease, i.e. how a patient’s disease will progress and their chances of recovery. The prediction is based on the usual course of the disease seen in similar patients without therapy.
Monitoring Disease Progress: The role of this biomarker it to monitor the progress of a disease, usually for diseases for which there is no effective therapy.
Risk Stratification: The role of this biomarker is to determine a person’s risk of suffering a particular clinical event within a specified period of time.
Risk Factor: The role of this biomarker is to determine a person’s risk of a disease on the basis of epidemiological evidence.
Screening: The role of this biomarker is to sort a population into ‘healthy’ and ‘non-healthy’. Screening is an epidemiological process, though the same process may serve for diagnosis as well.
Selection for Therapy: The role of this biomarker is to select a sub-group of patients suitable for a particular therapy.
Staging: The role of this biomarker is to describe how far a disease has progressed in a patient. The stage at diagnosis is often a prognostic indicator of overall survival and can be used as a guide for subsequent therapy.
- What are the definitions for types in Biomarkers Knowledge Area?
Anthropomorphic biomarkers: are of the body shape/ form, for example body mass index.
Cellular biomarkers: are whole cells, for example cancer cells identified by the Pap test.
Biochemical biomarkers: are chemical entities, for example glucose.
Genomic biomarkers: are variants in the DNA sequence and in the transcription level, for example HER2.
Physiological biomarkers: are body processes, for example systolic blood pressure.
Proteomic biomarkers: are variants in protein sequence, protein levels in a given tissue, proteins interactions, and enzyme activities.
Structural biomarkers: are physical images, for example colorectal tumor margin (image obtained by magnetic resonance imaging, MRI), carotid intimia media thickness.
- Who creates Biomarkers Knowledge Area?
There is a dedicated team of scientific analysts working exclusively in the biomarkers area. Their educational backgrounds include degrees in medicine, molecular biology and biochemistry. A separate team of PhD-qualified scientists is responsible for quality control. We also benefit from expert input from analysts working in the areas of genes, patents, kits, selection of literature, companies and markets. The full team is around 80 people.
- Is there an alerting function?
Not at present but this is planned to be included in a future release.
- Is it possible to search for a gene variant in Biomarkers Knowledge Area?
Genes are indexed in Biomarkers Knowledge Area using the name of the wild-type or predominant variant. Information on variants can then be found by linking to related information in the Genomics Knowledge Area, for example in gene-related studies. There will also be more detail in the references related to a specific use of interest. Of course, it is possible to search for a gene variant in the Genomics Knowledge Area and link to related records in Biomarkers Knowledge Area.
- Is it possible to search on free text?
A search in the description field is a free text search. Other fields use controlled vocabulary, rather than free text, to allow more accurate search and retrieval. It is recommended that users select controlled