3.5.2 Drug Development Process

• 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