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Topic 5: Health, Disease and the Development of Medicines
5.4 Developing Medicines
5.4.1 Drug Development
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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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