GAETANI SILVANA
(programma)
Stages of development of a drug-medicament. Identification of a new drug target. Evaluation of clinical candidates: pharmacodynamic activity of a new molecular entity. Pharmacogenomics in drug development.
Pharmacological studies pre-clinical studies. Main methods in vitro and in vivo. Good laboratory practices. Pharmacodynamic activity versus toxicity: Pre-clinical studies to assess the safety of a drug.
Medications and Pregnancy: teratogenic drug. Issues related to the presence of genotoxic and non genotoxic impurities and in medicinal products.
Types of clinical trials. Phases of clinical trials. Good clinical practice. Role of ethics committees. The Investigator's brochure. Registration of drugs at national and European level.
Pharmacovigilance: definition and tasks. Methods used in pharmacovigilance.
Definition and classification of adverse drug reactions.
"Basic Principles of Drug Discovery and Development" Benjamin Blass. Elsevier, April 2015
“Drug discovery and evaluation: Pharmacological assays”. H.G. Vogel (Ed.) Springer, London, 2007
|