Cards (44)

    • Stages in the drug development process
      1️⃣ Drug Discovery
      2️⃣ Pre-clinical Testing
      3️⃣ Clinical Trials
      4️⃣ Regulatory Approval
    • What is the purpose of target identification and validation in drug development?
      Relevance of biological targets
    • Steps in target identification and validation
      1️⃣ Target Selection
      2️⃣ Target Validation
      3️⃣ Modulation Assessment
    • The FDA and EMA are organizations that ensure drug safety and efficacy
    • Steps in lead compound discovery and optimization
      1️⃣ Lead Compound Discovery
      2️⃣ Lead Optimization
    • What is evaluated in in vitro preclinical studies?
      Toxicity, mechanism of action
    • Phase 1 clinical trials are relatively short in duration, lasting weeks to months.

      True
    • Regulatory approval ensures that the drug is safe and effective
    • Match the steps in lead compound discovery and optimization with their descriptions:
      Lead Compound Discovery ↔️ Screening chemical libraries to identify drug candidates
      Lead Optimization ↔️ Improving compound properties through testing
    • In vitro studies use cell cultures and test tubes to assess toxicity
    • What is the primary purpose of Phase 1 clinical trials?
      Assess safety and tolerability
    • What is the main goal of Phase 2 clinical trials?
      Assess efficacy
    • Which regulatory agencies approve drugs in the United States and Europe?
      FDA and EMA
    • What is the purpose of post-market surveillance?
      Detect and evaluate adverse events
    • Pre-clinical testing is conducted on humans to assess safety.
      False
    • Genetic and biochemical studies are used to validate the target
    • What are initial drug candidates identified in lead compound discovery called?
      Lead compounds
    • Lead compound discovery and optimization aims to identify promising drug candidates.

      True
    • Modulation assessment evaluates the drug's mechanism of action and safety profile.
      True
    • Lead compound discovery involves screening large libraries of chemical compounds to identify initial drug candidates
    • In Phase 1 clinical trials, the participants are typically healthy volunteers
    • Stages of the drug development process
      1️⃣ Drug Discovery
      2️⃣ Pre-clinical Testing
      3️⃣ Clinical Trials
      4️⃣ Regulatory Approval
    • Lead optimization aims to improve properties such as potency, selectivity, pharmacokinetics, and safety
    • Preclinical testing helps identify potential issues with drug candidates before human trials.

      True
    • Preclinical testing is optional in the drug development process.
      False
    • Phase 1 trials typically involve a small number of healthy volunteers
    • Phase 2 trials often use a randomized, placebo-controlled design
    • Regulatory approval ensures a drug is safe and effective for public use.

      True
    • The drug development process involves several key stages
    • Clinical trials involve three phases: safety, efficacy, and large-scale safety and efficacy
    • Target identification and validation is optional for drug discovery.
      False
    • Lead optimization aims to improve properties such as potency, safety, and selectivity
    • What is the primary focus of Phase 1 clinical trials?
      Safety
    • What are the properties of a lead compound that are improved during lead optimization?
      Potency, selectivity, pharmacokinetics, safety
    • Preclinical testing aims to assess a drug's safety and efficacy before human trials.
      True
    • What is the main focus of dosage in Phase 1 clinical trials?
      Determine maximum tolerated dose
    • What are the primary goals of the three phases of clinical trials?
      Phase 1: safety, Phase 2: efficacy, Phase 3: large-scale efficacy and safety
    • Target validation confirms the target's role in the disease process using in vitro and in vivo experiments.

      True
    • What is the focus of in vivo preclinical studies?
      Efficacy, dosage, toxicity
    • What are the two types of studies involved in preclinical testing?
      In vitro and in vivo
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