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Questions and Answers
What is the primary purpose of preclinical trials?
What is the main focus of clinical pharmacology?
Which type of pharmacology is concerned with drug effects on isolated tissue?
During which phase are drugs tested on patients who have the disease the drug targets?
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What defines a drug as a medicine?
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What is the typical outcome for drugs that enter the pharmaceutical development process?
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What is the problem with market surveillance of drugs?
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Which schedule of controlled substances has the highest abuse potential and no accepted medical use?
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How are semi-synthetic drugs made?
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What does pharmacodynamics study?
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What classification relates to the origin of the drug?
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Which schedule contains drugs with limited abuse potential, primarily small amounts of narcotics for specific uses?
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What aspect does toxicology focus on?
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Which term describes how genetics can influence where drugs act and how they operate?
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Which of the following is NOT a natural source of drugs?
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Study Notes
Pharmacology Basics
- Pharmacology studies drugs: their properties, effects, and uses.
- A drug becomes a medicine when used safely and at the correct dosage. All medicines are drugs, but not all drugs are medicines.
Areas of Pharmacology
- Clinical Pharmacology: Studies drug effects in humans (healthy volunteers and patients).
- Experimental Pharmacology: Studies drug effects in lab animals (in vitro – isolated tissue; in vivo – intact organism).
- Toxicology: Studies adverse drug reactions and their treatment.
- Pharmacogenetics: Explores how genetics influence drug action and response.
- Pharmacokinetics: How the body processes a drug (absorption, distribution, metabolism, excretion).
- Pharmacodynamics: How a drug affects the body (biochemical and physiological effects).
Drug Regulation and Controlled Substances
- Drug regulation is strict worldwide (e.g., Saudi Food and Drug Authority in Saudi Arabia).
- Controlled substances have high abuse potential and are categorized into schedules based on their risk:
- Schedule I (C-I): High abuse potential, no accepted medical use (e.g., heroin).
- Schedule II (C-II): High abuse potential, severe dependence liability (e.g., morphine).
- Schedule III (C-III): Lower abuse potential than Schedule II, moderate dependence liability (e.g., acetaminophen/codeine).
- Schedule IV (C-IV): Lower abuse potential than Schedule III, limited dependence liability (e.g., diazepam).
- Schedule V (C-V): Limited abuse potential, often small amounts of narcotics in over-the-counter medications (e.g., codeine cough suppressants).
Drug Development and Evaluation
- Drug development is a long, intensive process.
- A rigorous testing process is used to assess therapeutic and toxic effects:
- Preclinical trials: Drug testing in lab animals evaluating effects and adverse reactions.
- Phase 1 studies: Testing in healthy human volunteers.
- Phase 2 studies: Testing in patients with the target disease.
- Phase 3 studies: Large-scale patient testing (thousands of patients) to monitor effects and identify unexpected reactions.
- Post-marketing surveillance: Continued monitoring for adverse effects after market approval. Even years after approval, adverse effects might be discovered (e.g., thalidomide).
- Of 100,000 potential drug chemicals, only about 5 reach the market.
Drug Classification Criteria
- Drugs can be classified by: chemical structure, location of action, therapeutic purpose, or plant origin.
Sources of Drugs
- Natural Sources: Plants (e.g., morphine from poppy), animals/humans (e.g., insulin from pigs), microorganisms (e.g., penicillin), minerals (e.g., calcium, magnesium).
- Semi-synthetic Drugs: Chemically modified natural drugs; aiming for improved potency, stability, or reduced toxicity (e.g., ampicillin from penicillin-G).
- Synthetic Drugs: Drugs fully synthesized in the laboratory.
- Bio-synthetic Drugs: Drugs produced using biological processes.
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