Pharmacology: Drug Discovery and Development
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Questions and Answers

What is the primary purpose of Phase III clinical trials?

  • To confirm earlier efficacy results and identify adverse events (correct)
  • To identify the therapeutic indication of the drug
  • To select and characterize the dosage form
  • To formulate the marketed product
  • What is the average time it takes for FDA approval after NDA filing?

  • 2 to 5 years
  • 2 months to 1 year
  • 2 months to several years
  • 18 to 24 months (correct)
  • What is the purpose of pre-formulation in product development?

  • To identify the therapeutic indication of the drug
  • To characterize the physical and chemical properties of the active ingredient (correct)
  • To formulate the marketed product
  • To select and characterize the dosage form
  • What is the significance of Phase III clinical trials in drug development?

    <p>70% chance of the product reaching the market</p> Signup and view all the answers

    What is the purpose of formulation development in product development?

    <p>To develop initial drug formulations for early clinical studies</p> Signup and view all the answers

    What happens to drugs after FDA approval?

    <p>They are subject to ongoing review for adverse side effects</p> Signup and view all the answers

    What is considered during marketed product development?

    <p>The colour, size, shape, viscosity, skin feel, and production size</p> Signup and view all the answers

    What happens during the marketed product development stage?

    <p>The drug is placed on the market and patients are monitored for side effects</p> Signup and view all the answers

    What is the primary focus of Phase I clinical trials?

    <p>To test the absorption, metabolism, and excretion of the drug in the human body</p> Signup and view all the answers

    What is the purpose of studying drug metabolism during the preclinical phase?

    <p>To understand how the drug is absorbed, distributed, and excreted by the body</p> Signup and view all the answers

    What is included in the IND application submitted to the FDA?

    <p>The results of the preclinical work, the drug's chemical structure, side effects, and manufacturing information</p> Signup and view all the answers

    In what phase of clinical trials is the drug tested on healthy volunteers?

    <p>Phase I</p> Signup and view all the answers

    What is the primary goal of toxicity testing during the preclinical phase?

    <p>To determine the maximum dose of the drug that can be tolerated</p> Signup and view all the answers

    What is the typical duration of clinical trials?

    <p>2-10 years</p> Signup and view all the answers

    What is the purpose of the preclinical phase in drug development?

    <p>To determine the toxicity and efficacy of the drug in animal models</p> Signup and view all the answers

    How many phases are involved in clinical trials?

    <p>3</p> Signup and view all the answers

    What is the main difference between a Multiple Ascending Dose (MAD) study and a Single Ascending Dose (SAD) study?

    <p>The number of doses given to individual study subjects</p> Signup and view all the answers

    What is the primary purpose of a Single Ascending Dose (SAD) study?

    <p>To obtain a rough understanding of a drug's single dose pharmacokinetics</p> Signup and view all the answers

    What is reached in a Multiple Ascending Dose (MAD) study?

    <p>Steady state, when the rate of drug absorption is equal to the rate of drug elimination</p> Signup and view all the answers

    What is the benefit of a Multiple Ascending Dose (MAD) study over a Single Ascending Dose (SAD) study?

    <p>It provides empirical confirmation of steady state concentrations</p> Signup and view all the answers

    What is the significance of steady state concentrations in pharmacokinetics?

    <p>It is the point at which the rate of drug absorption is equal to the rate of drug elimination</p> Signup and view all the answers

    Why is a placebo used in Phase 2 clinical trials?

    <p>To understand and determine if the drug is really helping the patient</p> Signup and view all the answers

    What is the primary purpose of Phase 2 clinical trials?

    <p>To check the efficacy and impact of the drug on the body</p> Signup and view all the answers

    What is the significance of Phase 2 clinical trials in drug development?

    <p>It determines the chances of the product reaching the market</p> Signup and view all the answers

    Study Notes

    Drug Discovery and Development

    • The process of drug discovery and development involves several stages, including preclinical phase, clinical trials, and patenting.

    Preclinical Phase

    • Determine toxicity and efficacy in animal models.
    • Continuously study drug metabolism and test for toxicity.
    • Patent the drug.

    Clinical Trials

    • Design a manufacturing process to carry out clinical trials.
    • Submit an Investigational New Drug (IND) application to the FDA.
    • IND application includes preclinical work results, drug chemical structure, side effects, manufacturing information, and a detailed clinical trial plan.

    Clinical Trials Phases

    • Phase 1: Test drug on healthy volunteers (20-100) to determine toxicity relative to dose and screen for unexpected side effects.

    • Phase 1 also determines how the drug is absorbed, metabolized, and excreted.

    • Phase 1 usually lasts 3 years, and if passed, the chances of the product reaching the market are 70%.

    • Phase 2: Test drug on 100-500 patients with the disease or condition to check efficacy and impact on the body, and to continue Phase 1 safety estimation.

    • Some patients are given a placebo to understand and determine if the drug is really helping the patient.

    • If passed, the chances of the product reaching the market are 60%.

    • Phase 2 usually lasts 2 years.

    • Phase 3: Test drug on a larger group of patients (1000-5000) and compare with existing treatments and a placebo.

    • If passed, the New Drug Application (NDA) is submitted.

    NDA Filing

    • NDA contains all data supporting the efficacy and safety of the drug from preclinical and clinical studies.
    • Approval can take 2 months to several years, but on average, it takes around 18 to 24 months.

    Product Development

    • Pre-formulation involves characterization of the physical and chemical properties of the active ingredient, therapeutic indication, and route of administration.
    • Formulation development involves developing initial drug formulations for early clinical studies.
    • Marketed product considerations include color, size, shape, viscosity, skin feel, and more.

    Post-Market Monitoring

    • Drug is placed on the market and patients are monitored for side effects.

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    Description

    This quiz explores the process of drug discovery and development, including preclinical phase, patenting, and testing for toxicity and efficacy.

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