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Biological Evaluation in Drug Development

Code 12489
Year 1
Semester S2
ECTS Credits 6
Workload T(30H)/TP(30H)
Scientific area Química Medicinal
Entry requirements Not applicable.
Mode of delivery Face-to-face
Work placements Not applicable
Learning outcomes To enable students with general and specific knowledge and expertise underlying the process of discovery and non-clinical development of new drug candidate chemical entities. At the end of the curricular unit students should be able to delineate appropriate experimental protocols for evaluation of the pharmacological properties of new drug candidates. To develop critical skills and understand the ethical principles to consider in scientific research, with emphasis on the principle of the 3Rs.
Syllabus Drug discovery and development: classical approaches and new strategies. Introduction to the pharmacokinetic principles (drug absorption, distribution, metabolism and excretion) and to the pharmacodynamic concepts (dose-response curve, agonism and antagonism). Early efficacy, safety and pharmacokinetic assessment of drug candidates: in silico and in vitro models for pharmacological profiling of new chemical entities. Cell- and tissue-based models in pharmacological evaluation. Animal models in drug research: guidelines for the care and use of laboratory animals. Disease animal models to the pharmacodynamic evaluation of new drug candidates: cardiovascular, antidiabetic, anti-obesity, psychotropic and neurotropic, learning and memory, anti-inflammatory-analgesic-antipyretic, and anti-cancer activity. Non-clinical toxicology assays: single-dose and repeated-dose toxicity, genotoxicity, carcinogenicity, and reproductive toxicity.
Main Bibliography Rick, N.G. Rick (2009); Drugs from discovery to approval. 2nd Ed., Wiley-Blackwell. H.G. Vogel (2008); Drug Discovery and Evaluation: Pharmacological Assays. 3rd Ed., Springer T.N. Tozer and M. Rowland (2006); Introduction to Pharmacokinetics and Pharmacodynamics. 1st Ed., Lippincott Williams & Wilkins. European Medicines Agency Scientific Guidelines for Human Medicinal Products (Non-Clinical Guidelines: Toxicology). Multiple indexed scientific papers.
Language Portuguese. Tutorial support is available in English.
Last updated on: 2019-06-20

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