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Drug Development Process Flashcards

7 cards from real CNPR practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Drug Development Process flashcards as text

  1. Which preclinical requirement must be completed before an IND application can be filed with the FDA?

    Answer: Adequate toxicology and pharmacology studies in animals

    Before filing an IND, sponsors must complete animal toxicology and pharmacology studies sufficient to predict safety for initial human exposure.

  2. A drug's 'therapeutic index' (TI) measures the relationship between:

    Answer: The toxic dose and the effective dose — a narrow TI indicates a higher risk drug

    The therapeutic index (TD50/ED50) compares the dose causing toxicity to the dose producing the desired effect; a narrow TI means little margin between effective and harmful doses.

  3. What does 'off-label' drug use mean?

    Answer: Prescribing a drug for a use, population, or dose not listed in FDA-approved labeling

    Off-label use is legally permissible for physicians but pharmaceutical reps cannot promote drugs for unapproved indications.

  4. Which organization accredits pharmaceutical sales training programs and awards the CNPR certification?

    Answer: The National Association of Pharmaceutical Sales Representatives (NAPSRx)

    NAPSRx (National Association of Pharmaceutical Sales Representatives) administers and awards the CNPR certification for pharmaceutical sales professionals.

  5. In the context of clinical trials, 'informed consent' requires that:

    Answer: Participants voluntarily agree to a study after receiving complete information about risks and benefits

    Informed consent is an ethical and legal requirement ensuring participants understand the study's purpose, risks, and their right to withdraw before agreeing to participate.

  6. What is a 'surrogate endpoint' in clinical research?

    Answer: A measurable biological marker used as a substitute for a clinical outcome

    Surrogate endpoints (like cholesterol levels or tumor size) are biomarkers reasonably likely to predict clinical benefit, allowing faster trial completion than waiting for actual disease outcomes.

  7. The FDA's MedWatch program is designed to:

    Answer: Collect voluntary safety reports on adverse events and product problems from healthcare professionals and patients

    MedWatch is the FDA's safety information and adverse event reporting system, allowing healthcare professionals and patients to report safety concerns post-approval.