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    Pharma - Industry Terms

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    tushars2012
    This document defines various industry terms related to drug development and FDA approval processes. It provides concise explanations of terms like ANDA (Abbreviated New Drug Application), Accelerated Approval, Action Letter, Adverse Event, Advisory Committee, Amendment, Bioavailability, Bioequivalence, Clinical Trials, Compound, Dosage Form, Dose, Drug Products, Drug Substance, Effectiveness, FDA (Food and Drug Administration), GLP (Good Laboratory Practices), Incidence Rate, Informed Consent, IND (Investigational New Drug), New Drug, NDA (New Drug Application), NME (New Molecular Entity), Parallel Track Mechanism, Pharmacology, the various Phases

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    Pharma - Industry Terms

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    tushars2012
    69 views3 pages
    This document defines various industry terms related to drug development and FDA approval processes. It provides concise explanations of terms like ANDA (Abbreviated New Drug Application), Accelerated Approval, Action Letter, Adverse Event, Advisory Committee, Amendment, Bioavailability, Bioequivalence, Clinical Trials, Compound, Dosage Form, Dose, Drug Products, Drug Substance, Effectiveness, FDA (Food and Drug Administration), GLP (Good Laboratory Practices), Incidence Rate, Informed Consent, IND (Investigational New Drug), New Drug, NDA (New Drug Application), NME (New Molecular Entity), Parallel Track Mechanism, Pharmacology, the various Phases

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    This document defines various industry terms related to drug development and FDA approval processes. It provides concise explanations of terms like ANDA (Abbreviated New Drug Application), Accelerated Approval, Action Letter, Adverse Event, Advisory Committee, Amendment, Bioavailability, Bioequivalence, Clinical Trials, Compound, Dosage Form, Dose, Drug Products, Drug Substance, Effectiveness, FDA (Food and Drug Administration), GLP (Good Laboratory Practices), Incidence Rate, Informed Consent, IND (Investigational New Drug), New Drug, NDA (New Drug Application), NME (New Molecular Entity), Parallel Track Mechanism, Pharmacology, the various Phases

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    69 views3 pages

    Pharma - Industry Terms

    Uploaded by

    tushars2012
    This document defines various industry terms related to drug development and FDA approval processes. It provides concise explanations of terms like ANDA (Abbreviated New Drug Application), Accelerated Approval, Action Letter, Adverse Event, Advisory Committee, Amendment, Bioavailability, Bioequivalence, Clinical Trials, Compound, Dosage Form, Dose, Drug Products, Drug Substance, Effectiveness, FDA (Food and Drug Administration), GLP (Good Laboratory Practices), Incidence Rate, Informed Consent, IND (Investigational New Drug), New Drug, NDA (New Drug Application), NME (New Molecular Entity), Parallel Track Mechanism, Pharmacology, the various Phases

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    Industry Term

    Definition or Explanation Abbreviated New Drug Application, this is a simplified submission of an already approved drug. ANDAs are for products with the same or very closely related active ingredients, dosage, strength etc. A highly specialized mechanism intended to speed approval of drugs promising significant benefit over existing therapy for serious or life threatening illnesses. An official communication from the FDA to an NDA sponsor that informs of a decision by the agency.

    ANDA

    Accelerated Approval

    Action Letter

    Adverse Event

    Unwanted effects that occur and are detected in populations.

    Advisory Committee Amendment to an NDA

    A panel of outside experts convened periodically to advise on safety and efficacy issues about drugs.

    A submission to change or add information to an NDA or supplement not yet approved.

    Bioavailability

    Rate and extent to which a drug is absorbed or is otherwise available to the treatment site in the body.

    Bioequivalence

    Scientific basis on which generic and name brand drugs are compared. Human studies designed to distinguish a drugs effect from other influences. Such studies conducted in the U.S. must be under an approved IND and in accord with FDA rules on human studies. A chemical synthesized or prepared from natural sources that is evaluated for its biological activities in preclinical tests.

    Clinical Trials

    Compound

    Dosage Form

    The delivery system for a drug, such as a tablet, IV solution or cream.

    Dose

    The amount of drug administered to a patient or test subject at a single time.

    Drug Products

    The finished dosage form that contains a drug substance generally but not necessarily in association with other active or inactive ingredients. The active ingredient to diagnose, treat, cure, or prevent disease or affect the structure or function of the body.

    Drug Substance

    Effectiveness

    The desired measure of a drugs influence on a disease condition.

    FDA

    Food and Drug Administration

    GLP

    Good Laboratory Practices, FDA guidelines governing the conduct of Non Clinical studies from which data will be used to support applications for research or marketing permits. The rate at which new cases of disease, adverse reactions, or other events occur per unit of time in a given population at risk. The voluntary consent given by a patient to participate in a study after being informed of its purpose, method of treatment, procedures etc. Investigational New Drug, An application that a drug sponsor must submit to the FDA before beginning tests of a new drug on humans. A drug first investigated or proposed for marketing after 1938 that is, a drug that was not generally recognized as safe and effective. New Drug Application, An application requesting FDA approval to market a new drug for human use in interstate commerce. New Molecular Entity, A compound that can be patented, which has not been previously approved. Policy that makes promising investigational drugs for AIDS and other HIV related diseases more widely available under parallel track protocols, while the controlled trials essential to establish the safety and effectiveness of new drugs are conducted. The science that deals with the effect of drugs on living organisms.

    Incidence Rate

    Informed Consent IND

    New Drug

    NDA

    NME

    Parallel Track Mechanism

    Pharmacology

    Phase 1

    The first trials in humans that test a compound for safety, tolerance and pharmacokinetics. Pilot studies to define efficacy and safety in selected populations of patients with the disease or condition to be treated, diagnosed, or prevented. Expanded clinical trials intended to gather additional evidence of effectiveness for specific indications and to better understand safety and drug related adverse effects.

    Phase 2

    Phase 3

    Phase 4

    Studies performed after a drug is approved for marketing.

    PhRma

    Pharmaceutical Manufacturers Association

    Postmarketing Surveillance Preclinical studies

    FDAs ongoing safety monitoring of marketed drugs.

    Studies that test a drug on animals and other non human test systems.

    Priority Drugs

    A drug that appears to represent an advance over available therapy.

    Raw Data

    Researchers records of patients, charts, x-rays, hospital notes etc.

    Risk

    The probability of an event occurring during a specified period of time. Before a drug may be approved for marketing, the law requires the submission of test results adequate to show the drug is safe under the conditions of use in the proposed labeling. Reports that an NDA sponsor must submit to CDER about the safety information that may affect the use for which the drug will be approved. Any effect other than the primary intended effect resulting from drug or non-drug treatment or intervention.

    Safety

    Safety Update Report

    Side Effect

    Stability

    The drug products resistance to change of its physical and chemical properties.

    Supplement

    A marketing application submitted for changes in a product that already has an approved NDA. A laboratory finding or physical sign that may not, in itself, be a direct measurement of how a patient feels, functions or survives.

    Surrogate Endpoint

    Treatment IND

    A mechanism that allows investigational drugs to be used in expanded access protocols. Charges to drug firms for certain NDAs, drug products, and manufacturing establishments. FDA uses these fees to hire application reviewers, and to accelerate reviews using computer technology.

    User Fees

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