Mastering Drug Discovery
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Questions and Answers

Which phase of clinical trials typically involves a small group of healthy volunteers to determine the safety and adverse effects of a drug?

  • Phase IV
  • Phase I (correct)
  • Phase II
  • Phase III

During which phase of clinical trials is the drug tested for its effectiveness in a specific target population?

  • Phase I
  • Phase II (correct)
  • Phase IV
  • Phase III

Which phase of clinical trials involves a large number of patients with the disease to evaluate the effectiveness of the drug?

  • Phase III (correct)
  • Phase IV
  • Phase II
  • Phase I

What is the purpose of Phase IV clinical trials?

<p>To test the drug in a general population (B)</p> Signup and view all the answers

What is the duration of Phase II clinical trials?

<p>Months to 2 years (C)</p> Signup and view all the answers

Which phase of clinical trials typically involves a larger group of healthy volunteers or a small group of diseased patients to determine the safety and effectiveness of a drug?

<p>Phase II (C)</p> Signup and view all the answers

What is the purpose of Phase III clinical trials?

<p>To evaluate the effectiveness of the drug in a specific target population (C)</p> Signup and view all the answers

What is the approximate duration of Phase IV clinical trials?

<p>Forever (C)</p> Signup and view all the answers

What is the purpose of Phase I clinical trials?

<p>To determine the safety and adverse effects of a drug (D)</p> Signup and view all the answers

What is the purpose of Phase II clinical trials?

<p>To evaluate the effectiveness of the drug in a specific target population (D)</p> Signup and view all the answers

Phase IV clinical trials enroll a small group of healthy volunteers to determine the safety and adverse effects of a drug.

<p>False (B)</p> Signup and view all the answers

Phase I clinical trials test the drug in humans for the first time.

<p>True (A)</p> Signup and view all the answers

Phase III clinical trials compare the drug to standard intervention or non-interventional standard care.

<p>True (A)</p> Signup and view all the answers

Phase II clinical trials involve a larger group of healthy volunteers or a small group of diseased patients.

<p>True (A)</p> Signup and view all the answers

Phase IV clinical trials assess the effectiveness of the drug in the general population.

<p>True (A)</p> Signup and view all the answers

During which phase of clinical trials is the drug tested for its effectiveness in a specific target population?

<p>Phase III (B)</p> Signup and view all the answers

What is the purpose of Phase IV clinical trials?

<p>To evaluate the effectiveness of the drug in the general population (A)</p> Signup and view all the answers

What is the approximate duration of Phase II clinical trials?

<p>Months to 2 years (D)</p> Signup and view all the answers

Which phase of clinical trials involves a small group of healthy volunteers to determine the safety and adverse effects of a drug?

<p>Phase I (C)</p> Signup and view all the answers

What is the purpose of Phase II clinical trials?

<p>To evaluate the effectiveness of the drug in a specific target population (B)</p> Signup and view all the answers

Phase III clinical trials compare the drug to standard intervention or non-interventional standard care.

<p>True (B)</p> Signup and view all the answers

What is the purpose of Phase I clinical trials?

<p>To determine the safety and adverse effects of the drug (D)</p> Signup and view all the answers

What is the duration of Phase IV clinical trials?

<p>Forever (B)</p> Signup and view all the answers

Which phase of clinical trials typically involves a larger group of healthy volunteers or a small group of diseased patients to determine the safety and effectiveness of a drug?

<p>Phase II (C)</p> Signup and view all the answers

Phase IV clinical trials enroll a small group of healthy volunteers to determine the safety and adverse effects of a drug.

<p>False (A)</p> Signup and view all the answers

What makes a drug target a good target?

<p>Clinical need and commercial potential (B)</p> Signup and view all the answers

What is the druggable genome?

<p>The number of drug targets in the human genome (C)</p> Signup and view all the answers

What is the purpose of target identification and validation?

<p>To understand the molecular mechanisms of disease (B)</p> Signup and view all the answers

What is the primary goal of hit evaluation?

<p>To confirm hits (C)</p> Signup and view all the answers

What is lead optimisation?

<p>The re-examination of PD, PK, toxicity, selectivity, etc. (C)</p> Signup and view all the answers

What is included in an IND dossier submitted to the FDA?

<p>All of the above (D)</p> Signup and view all the answers

What does preclinical development involve?

<p>Toxicity testing (C)</p> Signup and view all the answers

What are the types of toxicity assessed in preclinical assessments?

<p>Nephrotoxicity, hepatotoxicity, immunotoxicity (B)</p> Signup and view all the answers

What is the purpose of Phase III clinical trials?

<p>To evaluate the safety and effectiveness of the drug in a large number of patients with the disease (B)</p> Signup and view all the answers

What is the purpose of Phase II clinical trials?

<p>To evaluate the safety and effectiveness of the drug in a large number of patients with the disease (A)</p> Signup and view all the answers

Which step in drug discovery involves identifying and validating a potential target for the drug?

<p>Target identification and validation (D)</p> Signup and view all the answers

What are the two main approaches to drug discovery mentioned in the text?

<p>Phenotype-based drug discovery and target-based drug discovery (D)</p> Signup and view all the answers

What is the rationale behind drug design during lead discovery and optimisation?

<p>Rationale drug design (C)</p> Signup and view all the answers

What is the purpose of preclinical assessment in drug development?

<p>To determine the safety and adverse effects of the drug (C)</p> Signup and view all the answers

What are the three phases of clinical trials mentioned in the text?

<p>Phase I, Phase II, Phase III (B)</p> Signup and view all the answers

Which phase of clinical trials involves testing the drug in a large number of patients with the disease to evaluate its effectiveness?

<p>Phase III (C)</p> Signup and view all the answers

What factors are considered when choosing a disease for drug discovery?

<p>Unmet medical need and economic viability (B)</p> Signup and view all the answers

What is the purpose of Phase II clinical trials?

<p>To determine the effectiveness of the drug in a specific target population (A)</p> Signup and view all the answers

What is the approximate duration of Phase III clinical trials?

<p>A few years (A)</p> Signup and view all the answers

What is the purpose of Phase IV clinical trials?

<p>To evaluate the safety and adverse effects of the drug in the general population (B)</p> Signup and view all the answers

What are the four major phases of drug development?

<p>Drug Discovery, Preclinical development, Clinical trials, Post-marketing surveillance</p> Signup and view all the answers

What is the purpose of Phase I clinical trials?

<p>To determine the safety and adverse effects of a drug</p> Signup and view all the answers

What is the purpose of Phase II clinical trials?

<p>To determine the safety, effectiveness, and dose of a drug in a specific target population</p> Signup and view all the answers

What is the purpose of Phase III clinical trials?

<p>To evaluate the effectiveness of a drug in a large number of patients with the disease</p> Signup and view all the answers

What is the purpose of Phase IV clinical trials?

<p>To assess the effectiveness of a drug in the general population and monitor safety and adverse effects</p> Signup and view all the answers

What is the approximate duration of Phase I clinical trials?

<p>Several months</p> Signup and view all the answers

What is the approximate duration of Phase II clinical trials?

<p>Months to 2 years</p> Signup and view all the answers

What is the approximate duration of Phase III clinical trials?

<p>1-3 years</p> Signup and view all the answers

What is the approximate duration of Phase IV clinical trials?

<p>1-2 years</p> Signup and view all the answers

What is the purpose of target identification and validation in drug discovery?

<p>To identify and validate a potential target for the drug</p> Signup and view all the answers

What are the major steps in current drug discovery and development?

<p>Target identification and validation, phenotype-based drug discovery, target-based drug discovery, lead discovery and optimisation, preclinical assessment of toxicity and safety, clinical assessment of efficacy, toxicity and safety.</p> Signup and view all the answers

What is the difference between phenotype-based drug discovery and target-based drug discovery?

<p>Phenotype-based drug discovery involves screening compounds for their ability to produce a desired phenotype, while target-based drug discovery involves identifying and validating a specific target for the drug.</p> Signup and view all the answers

What is lead optimisation?

<p>Lead optimisation is the process of refining and improving the properties of a lead compound to make it more effective and safe as a drug candidate.</p> Signup and view all the answers

What factors are considered when choosing a disease for drug discovery?

<p>Unmet medical need, economic viability, size of target population, feasibility of drug development, and information about the disease.</p> Signup and view all the answers

What is the purpose of preclinical assessment in drug development?

<p>The purpose of preclinical assessment is to evaluate the toxicity and safety of a drug candidate before it is tested in humans.</p> Signup and view all the answers

What are the three phases of clinical trials?

<p>Phase I, Phase II, and Phase III.</p> Signup and view all the answers

What is the purpose of Phase I clinical trials?

<p>The purpose of Phase I clinical trials is to evaluate the safety and dosage of a drug candidate in a small group of healthy volunteers.</p> Signup and view all the answers

What is the purpose of Phase II clinical trials?

<p>The purpose of Phase II clinical trials is to evaluate the effectiveness and side effects of a drug candidate in a larger group of patients.</p> Signup and view all the answers

What is the purpose of Phase III clinical trials?

<p>The purpose of Phase III clinical trials is to confirm the effectiveness and monitor side effects of a drug candidate in a larger population.</p> Signup and view all the answers

What is the purpose of Phase IV clinical trials?

<p>The purpose of Phase IV clinical trials is to monitor the long-term safety and effectiveness of a drug after it has been approved for marketing.</p> Signup and view all the answers

What are the key characteristics of a good drug target?

<p>Clinical need and commercial potential, involvement in disease pathophysiology, target-related safety, primarily expressed on tissues of interest, manageable on-target adverse effects, druggable, availability of assays for screening</p> Signup and view all the answers

What is the druggable genome?

<p>The subset of the human genome that can be modulated by low molecular weight compounds with 'drug-like' properties</p> Signup and view all the answers

What is the process of target identification and validation?

<p>It involves understanding the molecular mechanisms of the disease, which can sometimes be straightforward for monogenic diseases but often complex for polygenic diseases. It can also involve the use of big data and translational relevance.</p> Signup and view all the answers

What is the purpose of assay development and screening?

<p>To identify 'hits' by developing an assay amenable to high-throughput screening and using compound libraries to screen for compounds that elicit a desired phenotype.</p> Signup and view all the answers

What is lead optimisation and what does it involve?

<p>Lead optimisation is the process of evaluating and refining leads. It involves medicinal/synthetic chemistry, generating structural analogues, evaluating structure-activity relationships, and re-examining pharmacodynamics, pharmacokinetics, toxicity, and selectivity.</p> Signup and view all the answers

What is included in an IND dossier?

<p>An IND dossier includes information about the drug's toxicity profile, pharmacological profile (in vitro and in vivo), pharmacodynamic and pharmacokinetic data, dose information, chemical/manufacturing information, formulation, proposed clinical plans/protocols, and toxicity testing.</p> Signup and view all the answers

What are the types of toxicity assessed in preclinical assessments?

<p>The types of toxicity assessed in preclinical assessments include nephrotoxicity, hepatotoxicity, cell death (necrosis/apoptosis), hypersensitivity/immunosuppression, acute toxicity, genotoxicity, chronic toxicity, immunotoxicity, carcinogenicity, mutagenicity, and teratogenicity.</p> Signup and view all the answers

What factors are considered when choosing a disease for drug discovery?

<p>The factors considered when choosing a disease for drug discovery include clinical need, commercial potential, evidence that the target is involved in disease pathogenesis, and evidence that modifying the target alters the disease state.</p> Signup and view all the answers

What are the key steps involved in preclinical development?

<p>Preclinical development involves assay development and screening, hit and lead identification, lead optimisation, and preclinical assessments such as toxicity testing and pharmacological characterisation.</p> Signup and view all the answers

What is the rationale behind drug design during lead discovery and optimisation?

<p>The rationale behind drug design during lead discovery and optimisation is to generate or obtain structural analogues of leads, evaluate their structure-activity relationships, and re-examine their pharmacodynamics, pharmacokinetics, toxicity, and selectivity.</p> Signup and view all the answers

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