Discovery, pre-clinical testing, phase I, phase II, phase III,, FDA approval, additional post-marketing testing (number of potential compounds reduced with each step)
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Outline the typical NC development studies for NCE
Steps in drug discovery. Animal testing carried out throughout drug discovery (genetic toxicity, safety pharmacology, drug metabolism, reproductive toxicity testing, long term toxicity testing, carcinogenicity studies
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Describe the discovery of anti-ulcer drugs
Cimetidine (H2 receptor antagonists). Discovered by James Black. Used 5 bioassay systems (rational drug design), organ bath experiments
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What are the principle uses for animals? (1)
Used to understand physiological systems, pharmacological action of drugs and potential for new medicines. Statutory requirement to evaluate toxicity of any agent ingested by humans (e.g. medications, food additives, pesticides). Veterinary medicine
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What are the principle uses for animals? (2)
In UK - no animals used for cosmetic testing/household cleaner testing. Illegal to use great apes or wild-caught primates. Illegal to use an animal if there is any alternative
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Outline the history involving the need for regulation of pre-clinical testing
Initiation, acceleration, rationalisation, harmonisation. US Elixir sulfanilamide for throat infections, Japan's medicinal products, EU thalidomide, medicinal devices
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What is the therapeutic index?
Therapeutic window - between minimal therapeutic dose and maximal therapeutic dose with minimal side effects (toxicity outside window)
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Which animals are used to test trauma treatments?
Pigs (large animals, similar CV system to humans)
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Which animals are most commonly used for drug testing?
Rodent and non-rodent (mice and dogs)
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What are the 3Rs? (1)
Replacement (use alternatives where possible to animals). Reduction (not possible to avoid using animals then implement optimal design and analysis or techniques that reduce the number of animals)
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What are the 3Rs? (2)
Refinement (improve animal welfare using techniques which minimise severity of pain)
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Which factors are considered during drug testing?
Absorption to target site (reduce absorption into blood/reduce S/E), biological barriers, ADME, frequency of dosing, route of administration, number of animals tested, which animal to use
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State features of the standard toxicity study
Ascending doses for 28 days in animals, record BP, weight, blood samples, look at overall behaviour, autopsy (difficult to determine S/E such as headache and nausea)
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Ethics and Animal Testing
More info in lecture notes
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Outline the typical NC development studies for NCE
Back
Steps in drug discovery. Animal testing carried out throughout drug discovery (genetic toxicity, safety pharmacology, drug metabolism, reproductive toxicity testing, long term toxicity testing, carcinogenicity studies
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