3.5.2 Drug Development Process

• Regulatory bodies review clinical trial data to approve drug use.


  True
• Match the stage of the drug development cycle with its description:

  Preclinical Testing ↔️ Drugs are tested on animals

  Phase I Clinical Trials ↔️ Small-scale trials on healthy volunteers

  Phase II Clinical Trials ↔️ Trials on patients to evaluate effectiveness

  Regulatory Approval ↔️ Drug is approved by regulatory bodies
• Computer-aided drug design (CADD) uses computational models to predict drug-target interactions
• Preclinical studies ensure the drug is safe for human testing.


  True
• Post-market surveillance monitors drug safety and efficacy after regulatory approval
• What is the primary goal of preclinical testing in drug development?

  Assess safety and efficacy
• What is the main objective of Phase III clinical trials?

  Confirm efficacy and monitor rare side effects
• Match the clinical trial phase with its primary purpose:

  Phase I ↔️ Assess safety and dosage

  Phase II ↔️ Evaluate effectiveness

  Phase III ↔️ Confirm efficacy and monitor side effects
• Preclinical studies are crucial for assessing the safety and efficacy of drug candidates.
• Steps involved in in vivo testing during preclinical studies

  1️⃣ Drug administration to animal models

  2️⃣ Study drug absorption, distribution, metabolism, and excretion (ADME)

  3️⃣ Monitor effects on the whole organism
• The drug development process ensures that only safe and effective drugs reach the market.


  True
• Preclinical studies are crucial to assess the safety and efficacy
• Data from preclinical studies must demonstrate safety and efficacy before clinical trials.

  True
• Phase I clinical trials focus on safety and determining the optimal dosage
• Phase I clinical trials involve testing the drug on healthy volunteers
• Regulatory approval is required before a drug can be marketed and sold.

  True
• What is high-throughput screening (HTS) used for in drug discovery?

  Testing large compound libraries
• What does in vitro testing involve in preclinical studies?

  Testing in isolated systems
• What must preclinical data demonstrate to proceed to clinical trials?

  Drug safety and efficacy
• Match the preclinical testing type with its focus:

  In vitro ↔️ Mechanism of action and toxicity

  In vivo ↔️ ADME and whole-organism effects
• Match the type of preclinical testing with its description:

  In vitro ↔️ Testing in isolated cells or tissues

  In vivo ↔️ Testing in animal models
• Order the phases of clinical trials in drug development:

  1️⃣ Phase I

  2️⃣ Phase II

  3️⃣ Phase III
• What is monitored in Phase III clinical trials?

  Rare side effects
• The final step in drug development is regulatory approval
• What is high-throughput screening (HTS) used for in drug discovery?

  Testing large compound libraries
• Order the steps in preclinical studies:

  1️⃣ In vitro testing

  2️⃣ In vivo testing
• Match the clinical trial phase with its purpose:

  Phase I ↔️ Assess safety and dosage

  Phase II ↔️ Evaluate effectiveness

  Phase III ↔️ Confirm efficacy and monitor side effects
• Regulatory bodies can withdraw a drug from the market if safety concerns arise during post-market surveillance.


  True