Questions and Answers
What was a significant advancement in drug discovery during the 1970s?
Which phase of clinical trials is primarily focused on studying the safety of a drug?
In what decade did the antibiotic era significantly boost research and development due to World War II?
What is one of the purposes of high-throughput screening in drug discovery?
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Which of the following approaches was primarily utilized in drug discovery during the 1990s?
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What is NOT a focus area in the preclinical phase of drug development?
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What technological advancement significantly influenced drug discovery in the 1980s?
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How many compounds are typically reviewed by the FDA before approving one new drug?
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What is the primary grading distribution for the lecture portion of the Pharmacology course?
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Which of the following best defines pharmacology?
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What is the lecture schedule for the Pharmacology course on Mondays?
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What does the acronym SGD stand for in the laboratory format?
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Which aspect is not a learning outcome for the course?
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Which figure is the chairman of the Pharmacology course?
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What is the primary focus of contemporary drug discovery?
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What is the total duration of the Pharmacology course?
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What is the primary focus of Phase II clinical trials?
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What is the sample size range for Phase III clinical trials?
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Which phase of clinical trials involves the most comprehensive assessments of drug interactions?
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How long can the patent protection for a drug last after its filing?
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What is typically assessed during Phase I trials?
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Which stage requires the longest duration of time in the drug development process?
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What is the percentage of drug development costs attributed to clinical trials (Phase I, II, III)?
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What type of study design is commonly used in Phase III clinical trials?
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What is the main objective of Phase IV trials?
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During which phase are human toxicity and tolerability evaluated?
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Study Notes
Course Introduction
- Pharmacology is a crucial second-year subject, spanning one year.
- Primary textbook: Goodman and Gilman’s Pharmacological Basis of Therapeutics, 13th edition (2018).
- Course chaired by Dr. Genevieve Dable-Tupas, RN, MD, MMCE, FPPS, FPSECP.
Lecture and Laboratory Schedule
- IMD 23A: Lectures on Mondays, 1-2:30 PM and 3-4:30 PM; Laboratory from 5:00-7:00 PM.
- IMD 23B: Lectures on Thursdays, 1-2:30 PM and 3-4:30 PM; Laboratory from 5:00-7:00 PM.
- Case studies integrated into M-TBL (Team-Based Learning) and SGD (Small Group Discussion).
- Grading breakdown: Lecture (65%: 40% quizzes, 60% term exam) and Laboratory (35%).
Learning Outcomes
- Review of physiology, biochemistry, and pathology.
- Grasping basic pharmacology principles tied to biological sciences.
- Application of theoretical knowledge to case studies and real-life scenarios.
Definition of Pharmacology
- Derived from Greek words for "poison" (φάρμακον) and "study of" (-λογία).
- Field focuses on drug study, emphasizing the significance of molecular and physiological levels.
History and Evolution of Drug Discovery
- Drug discovery has evolved from herbal remedies to advanced modern chemistry and biotechnology.
- Key historical milestones:
- Pre-1919: Herbal drugs and serendipitous discoveries.
- 1920s-1940s: Introduction of vitamins, vaccines, and antibiotics.
- 1970s-1990s: Rise of biotechnology, IT utilization, and automation in drug discovery.
Drug Discovery Process
- Involves multiple phases from target selection to clinical trials.
- Key components include:
- Target selection, lead discovery, medicinal chemistry, in vitro and in vivo studies, and clinical trials.
Clinical Trials Overview
- Classifies into four phases (I-IV), each critical for assessing safety and efficacy:
- Phase I: Initial testing in 10-100 healthy volunteers focusing on safety and tolerability (months to 1 year).
- Phase II: Expanded controlled trials with 50-500 participants determining efficacy and dosing (1-2 years).
- Phase III: Larger trials (250-1000 patients) assessing safety, efficacy, and comparison with other treatments (3-5 years).
- Phase IV: Post-marketing surveillance for long-term effects and interactions, involving thousands of participants.
Drug Development Timeline
- Typically, ~10,000-25,000 compounds are screened, with only about 1 FDA-approved drug emerging from this process.
- Total duration for drug development comprises approximately 15 years: ~6.5 years in preclinical research, followed by clinical trials taking about 7 years and FDA review for ~1.5 years.
Drug Development Costs
- Cost breakdown of R&D functions:
- Discovery/Basic Research: 10%
- Biological Screening & Testing: 14.2%
- Clinical Trials: 29.1% collectively for Phases I-III, and 11.7% for Phase IV.
- Total spending equals 100%.
Intellectual Property and Patents
- Grants companies exclusive rights to sell developed products for 20 years post-filing.
- Drug development typically takes 10-15 years, allowing for 10-12 years of market protection upon approval.
- Intellectual property implications are significant in the commercialization of pharmaceuticals.
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Description
Test your knowledge on the key concepts presented in Goodman and Gilman's Pharmacological Basis of Therapeutics, 13th edition. This quiz covers essential topics from case studies and laboratory sessions integral to the pharmacology curriculum for second-year students. Prepare for your assessments and enhance your understanding of pharmacology.
