Drug Discovery and Development Quiz
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Questions and Answers

What is the primary focus during Phase 1 studies of drug testing?

  • Long-term effects of the drug
  • Safety of the drug (correct)
  • Efficacy of the drug
  • The pharmacokinetics of the drug

Which of the following is NOT a source of active ingredients for drugs?

  • Mammalian hormones
  • Plant extracts
  • Synthetic compounds
  • Radioactive materials (correct)

What must a sponsor develop before filing an IND with the FDA?

  • A marketing strategy
  • A distribution plan
  • A manufacturing timeline
  • A pharmacologic profile of the drug (correct)

How long does the FDA have to respond to an IND application before a sponsor can begin clinical trials?

<p>30 days (A)</p> Signup and view all the answers

Which type of scientists is NOT typically included in the drug research and development team?

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

Which of the following statements about the IND review process is true?

<p>A clinical hold can be issued if the FDA identifies risk to subjects. (C)</p> Signup and view all the answers

What is the primary focus of Phase 2 studies in drug development?

<p>Effectiveness and short-term side effects (B)</p> Signup and view all the answers

What is included in a New Drug Application (NDA)?

<p>Animal and human data, and how the drug is manufactured (D)</p> Signup and view all the answers

What is the FDA's timeframe to review and decide on an NDA after filing?

<p>60 days (C)</p> Signup and view all the answers

In Phase 3 studies, what aspect is primarily studied?

<p>Effectiveness in combination with other drugs (D)</p> Signup and view all the answers

What does the FDA's review of drug labeling aim to ensure?

<p>Accurate information for healthcare professionals and consumers (D)</p> Signup and view all the answers

What distinguishes Adverse Drug Reactions (ADRs) from side effects?

<p>ADRs can be life-threatening and unpredictable (A)</p> Signup and view all the answers

What option is NOT available to the FDA or drug manufacturers when adverse events are confirmed?

<p>Revoke all licenses of the manufacturer (C)</p> Signup and view all the answers

What do post-market requirement studies entail?

<p>Studies required by the FDA after product approval (C)</p> Signup and view all the answers

What is the primary mission of the Human Genome Project?

<p>To decipher the complete human genome and identify genes (C)</p> Signup and view all the answers

What defines a surrogate marker in therapeutic trials?

<p>A laboratory measurement that approximates a meaningful clinical endpoint (B)</p> Signup and view all the answers

What is metabolomics primarily concerned with?

<p>The large-scale study of small molecules called metabolites (A)</p> Signup and view all the answers

Which technique is NOT typically associated with rational drug design?

<p>Clinical trials using human subjects (B)</p> Signup and view all the answers

What benefit do new methods of drug discovery provide?

<p>They can make drug development more efficient and cost-effective (C)</p> Signup and view all the answers

Which approach does Rational Drug Design primarily depend on?

<p>Knowledge of biomolecular structures and functions (A)</p> Signup and view all the answers

What is the key distinction between post-marketing requirements (PMRs) and post-marketing commitments (PMCs)?

<p>PMRs are required by law, whereas PMCs are agreed upon voluntarily. (C)</p> Signup and view all the answers

What factor is crucial for the FDA to approve a drug?

<p>Proven efficacy and safety data. (A)</p> Signup and view all the answers

How long does it typically take to develop a new pharmaceutical agent?

<p>8 to 15 years. (A)</p> Signup and view all the answers

What primarily drives up the research and development costs in pharmaceuticals?

<p>Contract studies in clinical and preclinical areas. (B)</p> Signup and view all the answers

What is a newly approved drug, also known as a patent drug?

<p>A novel drug developed by the original innovator with a patented name. (B)</p> Signup and view all the answers

What defines a generic drug?

<p>An identical copy in active ingredients and strength marketed by a different company. (D)</p> Signup and view all the answers

What ensures that non-prescription drugs meet the same safety standards as prescription drugs?

<p>The same FDA standards apply for both categories. (C)</p> Signup and view all the answers

What is the expected marketing exclusivity period for a newly approved drug under patent?

<p>20 years. (B)</p> Signup and view all the answers

Which significant advancement is influencing drug discovery processes?

<p>The human genome project. (C)</p> Signup and view all the answers

What aspect of the drug development process often leads to the need for post-marketing requirements?

<p>The potential for long-term side effects that were not previously identified. (A)</p> Signup and view all the answers

Flashcards

Drug Discovery Sources

Drugs are derived from plants, mammalian hormones, microorganisms, semisynthetic, and synthetic compounds. Natural sources include plant extracts, animal hormones, and microorganisms.

Drug Research Team

A team of scientists with diverse expertise, including pharmaceutical chemistry, pharmaceutics, clinical toxicology, clinical pharmacology, and biopharmaceutics, works together to develop drugs.

Pre-clinical Phase

The initial stages of drug development that involve lab studies and animal testing to assess drug safety and effectiveness.

IND Application

A formal submission to the FDA (Food and Drug Administration) to seek permission to test a new drug in humans.

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Clinical Trials Phases

A series of three phases (1, 2, and 3) to evaluate safety and effectiveness of a drug in humans, with increasing numbers of participants.

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FDA Drug Approval Process

A multi-step process involving pre-clinical testing, IND review, clinical trials, and final NDA submission to ensure drug safety and efficacy before approval for use.

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Phase 2 Drug Trials

Drug trials focusing on effectiveness, evaluating safety, and studying short-term side effects with a few dozens to few hundreds of patients.

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Phase 3 Drug Trials

Trials assessing drug safety and effectiveness in diverse populations, different dosages, and in combination with other drugs, involving several hundreds to several thousands of patients.

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New Drug Application (NDA)

Comprehensive document submitted to the FDA, containing animal and human data, drug behavior, and manufacturing information.

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FDA Review Time (Priority Drugs)

The FDA aims for a six-month review period for priority drugs after an NDA is submitted.

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Drug Labeling Review

FDA ensures appropriate information on the drug is communicated to healthcare professionals and consumers.

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Adverse Drug Reaction (ADR)

Moderate to severe, sometimes life-threatening, unpredictable effects of a drug.

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Post-Market Surveillance (PMS)

Monitoring drug safety after FDA approval.

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Post-marketing studies

Required studies conducted after a drug is approved for sale to gather further safety and effectiveness data.

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Human Genome Project

An international research project aimed at mapping the entire human genetic material, identifying all genes, and creating tools to analyze this genetic information.

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Surrogate Marker

A laboratory measurement or physical sign used in clinical trials to predict how a patient will respond to a therapy, without directly measuring their overall health.

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Metabolomics

The study of small molecules (metabolites) within cells, fluids, tissues, or organisms, to understand their interactions and roles in biological systems.

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Rational Drug Design

A method of developing drugs by understanding how a target molecule (protein or nucleic acid) works and creating a drug that interacts with it in a specific way.

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Computational Chemistry

Using computer simulations to study and predict how molecules interact with each other, aiding in drug design.

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X-ray Crystallography

A technique for determining the 3-dimensional structure of a molecule by analyzing how X-rays interact with it.

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Post-marketing requirements (PMRs)

Studies that drug sponsors are legally obligated to conduct after a drug is approved, typically to assess long-term effects or specific populations.

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Post-marketing commitments (PMCs)

Studies that drug sponsors voluntarily agree to conduct after a drug is approved, often to further investigate a drug's potential uses or address specific concerns.

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FDA drug approval criteria

The FDA only approves a drug if the submitted data demonstrates that the drug is both safe and effective for its intended use.

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Drug development timeline

Developing a new drug typically takes 8 to 15 years, involving extensive research, testing, and regulatory processes.

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Key drivers of drug development costs

Contract studies, particularly those related to clinical trials, preclinical toxicology, and analytical sample testing, contribute significantly to the high cost of drug research.

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Patent drug

A brand-new drug developed by an innovator company, with exclusive marketing rights protected by a patent.

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Generic drug

A drug that is chemically identical to a brand-name drug but marketed by a different company after the patent expires.

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Non-prescription drug

A drug that is considered safe and effective enough to be sold over-the-counter without a doctor's prescription.

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Impact of the Human Genome Project on drug discovery

The Human Genome Project has revolutionized drug discovery by providing a deeper understanding of genes and their roles in disease, enabling more targeted and personalized medicine approaches.

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FDA approval process overview

The FDA carefully evaluates drug safety and efficacy through a multi-step process involving preclinical testing, clinical trials, and review of data before approving a drug for use.

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Study Notes

Drug Discovery

  • Drugs are extracted from plants, mammalian hormones/microorganisms, and semi/synthetic compounds
  • Plant poisons include morphine (opium poppy) and digitalis (foxglove)
  • Inorganic chemicals include potassium, sodium, chloride, and calcium
  • Biologics include insulin, estrogen hormones, epinephrine, and diphtheria antitoxin
  • Drugs are also extracted from algae, invertebrates, and sponges

Drug Research & Development Team

  • A team of scientists from various disciplines are involved
  • Disciplines include pharmaceutical chemistry, pharmaceutics, clinical toxicology, clinical pharmacology, biopharmaceutics, and clinical pharmacokinetics

FDA Drug Approval Process

  • Drug discovery and development takes 2-10 years
  • Pre-clinical research and development includes:
    • Initial synthesis of substances
    • Laboratory and animal testing
    • Institutional Review Board (IRB) review/approval
  • Clinical trials are divided into phases:
    • Phase 1: testing on healthy volunteers (sample size: ~20-80)
    • Phase 2: testing on patients with the disease (sample size: few dozens/few hundreds)
    • Phase 3: larger scale testing on patients with the disease, comparing with existing treatments and different dosages (sample size: hundreds to thousands)
  • NDA submission, review, and FDA response takes 1-2 years
  • Then, a post-market surveillance phase follows
  • During post-market surveillance, adverse events are monitored
  • Possible FDA and drug manufacturer responses include altering directions, or warning about use

IND Review

  • The FDA assesses if it is safe to test the drug on humans, this requires review of the NDA/IND
  • The FDA has 30 days to respond to the sponsor
  • If no response is given within 30 days, sponsor can initiate trials
  • FDA can delay or stop trials if a risk is identified

FDA Drug Approval

  • FDA approves drugs only when submitted data proves efficacy and safety
  • FDA advisory committees ensure benefits outweigh risks

Time and Cost of Drug Development

  • Drug development can take 8-15 years
  • High priority drugs can be approved faster
  • The biggest cost driver is contract studies in clinical and preclinical areas (like toxicology or analytical sample costs)

Timeline of Drug Development

  • Target identification (0-2 years)
  • Target selection (0-2 years)
  • Discovery and screening (2-3 years)
  • Lead selection (1-2 years)
  • Lead optimization (1-2 years)

Drug Manufacturing

  • Once the NDA is approved, manufacturing can begin
  • Drugs can be categorized as newly approved (patent drug), generic drug, non-prescription drug
  • Newly approved drug (patent drug): Original product research by a drug company. They patent the drug to market for 20 years, then other drug companies can develop a generic version
  • Generic Drug: identical copy in active ingredients, formulation and strength to the original
  • Non-prescription Drug: FDA applies same standards for non-prescription drug as it does for prescription drug, if proposed OTC drug meets criteria

Future of Drug Discovery

  • The human genome project impacts how drugs are discovered and developed.
  • Surrogate markers can predict long-term outcomes
  • Metabolomics is crucial, identifying unique patterns in small molecules
  • New methods are emerging:
    • Rational drug design
    • Powerful computers
    • Computational chemistry
    • X-ray crystallography
    • Nuclear magnetic resonance spectroscopy
    • 3-Dimensional Structure-Activity Relationship analysis

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Drug Discovery, Testing & Approval Process PDF

Description

Test your knowledge on the processes involved in drug discovery and development. This quiz covers aspects such as sources of drugs, the research and development team, and the FDA drug approval process. Challenge yourself and learn how drugs are researched, created, and approved for use.

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