3.5.2 Drug Development Process

Cards (41)

  • The first step in the drug development process is to identify a disease target
  • Identifying a disease target is the focus for subsequent steps such as screening for drug candidates
  • Drug Design involves optimizing drug molecules based on the disease target's structure and function.
  • High-throughput screening is an example of Drug Discovery
  • Match the type of testing with its purpose:
    In vitro testing ↔️ Evaluates drug effects on cells and tissues
    In vivo testing ↔️ Evaluates efficacy and safety in animals
  • In vivo testing assesses whether the drug can effectively treat the disease
  • What is the primary focus of Drug Design in drug development?
    Optimizing drug molecules
  • Screening in Drug Discovery involves testing large libraries of chemical compounds.

    True
  • Drug Discovery uses screening of existing compounds, while Drug Design uses rational design based on target structure
  • What are the two main types of preclinical testing in drug development?
    In vitro and in vivo
  • Preclinical testing aims to gather data on the drug's safety and efficacy before clinical trials.

    True
  • In Phase 1 trials, participants are healthy volunteers
  • Primary goals of Phase 1 clinical trials
    1️⃣ Assess safety profile
    2️⃣ Determine safe dosage range
    3️⃣ Identify side effects
  • Phase 2 clinical trials focus on evaluating the efficacy of the drug in patients with the condition.
    True
  • Drug Design uses a rational approach based on the disease target's structure.
    True
  • What does in vitro testing evaluate in preclinical testing?
    Effects on cells and tissues
  • Order the phases of clinical trials based on their primary focus:
    1️⃣ Phase 1: Safety, dosage
    2️⃣ Phase 2: Efficacy, side effects
    3️⃣ Phase 3: Efficacy, safety in larger group
    4️⃣ Phase 4: Long-term effects
  • What is the primary goal of Phase 2 clinical trials?
    Evaluate drug efficacy
  • Phase 3 trials provide data needed for regulatory approval.

    True
  • Phase 4 clinical trials monitor the long-term effects and safety of approved drugs in real-world conditions
  • Order the stages in the drug development process
    1️⃣ Identify a Disease Target
    2️⃣ Drug Discovery and Design
    3️⃣ Preclinical Testing and Development
    4️⃣ Clinical Trials: Phase 1
    5️⃣ Clinical Trials: Phase 2
    6️⃣ Clinical Trials: Phase 3
    7️⃣ Regulatory Approval
    8️⃣ Post-Market Monitoring and Safety Surveillance
  • Researching the underlying causes of a disease is part of identifying a disease target.

    True
  • Match the term with its definition:
    Drug Discovery ↔️ Identifying potential drug candidates
    Drug Design ↔️ Designing and optimizing drug molecules
  • Drug Discovery involves screening existing compounds to find potential drug candidates.

    True
  • Computer-aided drug design is an example of Drug Design.

    True
  • Pharmacokinetics refers to how the body absorbs, distributes, metabolizes, and eliminates the drug
  • Preclinical testing gathers data on drug safety and efficacy before clinical trials.

    True
  • Drug Discovery identifies potential drug candidates, while Drug Design optimizes molecules
  • What does lead optimization aim to improve in promising drug candidates?
    Potency, selectivity, pharmacokinetics
  • Match the approach with its example:
    Drug Discovery ↔️ High-throughput screening
    Drug Design ↔️ Structure-based drug design
  • In vitro testing evaluates the drug candidate's effects on cells and tissues, while in vivo testing uses animals
  • What is the primary focus of Phase 1 clinical trials?
    Safety and dosage
  • Match the clinical trial phase with its primary goal:
    Phase 1 ↔️ Assess safety
    Phase 2 ↔️ Evaluate efficacy
  • In Phase 2 trials, potential side effects are monitored in patients
  • What is the first step in drug development?
    Identifying a disease target
  • Drug Discovery includes screening chemical libraries and optimization
  • Match the approach with its example:
    Drug Discovery ↔️ High-throughput screening
    Drug Design ↔️ Structure-based drug design
  • The purpose of preclinical testing is to gather data on safety and efficacy
  • Phase 1 clinical trials use healthy volunteers to assess safety.
    True
  • Phase 3 clinical trials confirm efficacy and safety