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?

30 days Signup and view all the answers

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

Market Analyst Signup and view all the answers

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

A clinical hold can be issued if the FDA identifies risk to subjects. Signup and view all the answers

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

Effectiveness and short-term side effects Signup and view all the answers

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

Animal and human data, and how the drug is manufactured Signup and view all the answers

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

60 days Signup and view all the answers

In Phase 3 studies, what aspect is primarily studied?

Effectiveness in combination with other drugs Signup and view all the answers

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

Accurate information for healthcare professionals and consumers Signup and view all the answers

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

ADRs can be life-threatening and unpredictable Signup and view all the answers

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

Revoke all licenses of the manufacturer Signup and view all the answers

What do post-market requirement studies entail?

Studies required by the FDA after product approval Signup and view all the answers

What is the primary mission of the Human Genome Project?

To decipher the complete human genome and identify genes Signup and view all the answers

What defines a surrogate marker in therapeutic trials?

A laboratory measurement that approximates a meaningful clinical endpoint Signup and view all the answers

What is metabolomics primarily concerned with?

The large-scale study of small molecules called metabolites Signup and view all the answers

Which technique is NOT typically associated with rational drug design?

Clinical trials using human subjects Signup and view all the answers

What benefit do new methods of drug discovery provide?

They can make drug development more efficient and cost-effective Signup and view all the answers

Which approach does Rational Drug Design primarily depend on?

Knowledge of biomolecular structures and functions Signup and view all the answers

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

PMRs are required by law, whereas PMCs are agreed upon voluntarily. Signup and view all the answers

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

Proven efficacy and safety data. Signup and view all the answers

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

8 to 15 years. Signup and view all the answers

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

Contract studies in clinical and preclinical areas. Signup and view all the answers

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

A novel drug developed by the original innovator with a patented name. Signup and view all the answers

What defines a generic drug?

An identical copy in active ingredients and strength marketed by a different company. Signup and view all the answers

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

The same FDA standards apply for both categories. Signup and view all the answers

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

20 years. Signup and view all the answers

Which significant advancement is influencing drug discovery processes?

The human genome project. Signup and view all the answers

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

The potential for long-term side effects that were not previously identified. Signup and view all the answers

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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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.