2.6.5 Drug Development

• High-throughput screening tests thousands of compounds to see if they interact with the target
• Phase I clinical trials typically involve 20-100 healthy volunteers
• Lead compounds are developed to improve their effectiveness and safety


  True
• What is monitored in Phase IV of clinical trials?

  Long-term effects
• Stages of drug development

  1️⃣ Identify potential drug targets

  2️⃣ Screen compounds

  3️⃣ Develop lead compounds

  4️⃣ Conduct preclinical trials

  5️⃣ Perform clinical trials

  6️⃣ Gain regulatory approval
• What is assessed during preclinical trials?

  Safety and efficacy
• Preclinical trials use both in vitro and in vivo testing methods.


  True
• Match the clinical trial phase with its objectives:

  Phase I ↔️ Assess safety

  Phase II ↔️ Evaluate effectiveness

  Phase III ↔️ Confirm effectiveness
• Steps in the drug discovery process

  1️⃣ Identify potential drug targets

  2️⃣ Screen compounds

  3️⃣ Develop lead compounds

  4️⃣ Conduct preclinical trials

  5️⃣ Perform clinical trials

  6️⃣ Gain regulatory approval
• What is the final step in the drug discovery process?

  Gain regulatory approval
• Clinical trials in humans are divided into four phases.


  True
• Preclinical trials involve testing on human participants.

  False
• Stages of the drug development process in the correct order

  1️⃣ Identify potential drug targets

  2️⃣ Screen compounds

  3️⃣ Develop lead compounds

  4️⃣ Conduct preclinical trials

  5️⃣ Perform clinical trials

  6️⃣ Gain regulatory approval
• One objective of preclinical trials is to identify potential toxicities
• Phase IV clinical trials monitor long-term effects in large patient populations
• Nanotechnology uses nanoparticles to improve drug delivery
• Steps in the drug discovery process

  1️⃣ Identify potential drug targets

  2️⃣ Screen compounds

  3️⃣ Develop lead compounds

  4️⃣ Conduct preclinical trials

  5️⃣ Perform clinical trials

  6️⃣ Gain regulatory approval
• Match the phase of clinical trials with its objectives:

  Phase I ↔️ Assess safety, dosage, side effects

  Phase II ↔️ Evaluate effectiveness, refine dosage

  Phase III ↔️ Compare to existing treatments

  Phase IV ↔️ Post-market surveillance
• Stages of the drug development process

  1️⃣ Identify potential drug targets

  2️⃣ Screen compounds

  3️⃣ Develop lead compounds

  4️⃣ Conduct preclinical trials

  5️⃣ Perform clinical trials

  6️⃣ Gain regulatory approval
• What is the final step in the drug development process?

  Gain regulatory approval
• What is required for developing antiviral drugs for influenza?

  Understanding the viral life cycle
• The most promising compounds are refined to enhance their effectiveness
• What is the primary goal of Phase III clinical trials?

  Confirm effectiveness
• Why were preclinical trials conducted for antiviral drugs for influenza?

  Ensure safety and efficacy
• The drug discovery process includes identifying biological pathways involved in diseases.


  True
• Phase IV of clinical trials involves post-market surveillance for long-term effects
• What type of trials are conducted on cells and animal models to determine drug safety?

  Preclinical trials
• High-throughput screening is used to test thousands of chemical compounds
• Phase III clinical trials compare the drug to existing treatments
• What is the primary purpose of preclinical trials?

  Assess safety and effectiveness
• What is the main objective of Phase I clinical trials?

  Assess safety and dosage
• What does the safety standard of efficacy measure in drug regulation?

  Drug's therapeutic effect
• The process of drug discovery involves identifying and developing compounds that can treat or prevent diseases
• Preclinical trials involve testing compounds on human volunteers

  False
• The development of antiviral drugs for influenza required understanding the virus's life cycle
• Clinical trials are divided into phases to ensure the drug's safety
• Submitting data to the FDA is necessary to gain regulatory approval for marketing a drug.


  True
• What do researchers identify in the first stage of drug development?

  Potential drug targets
• How many healthy volunteers are typically involved in Phase I clinical trials?

  20-100
• One objective of preclinical trials is to identify potential toxicities