Preclinical and Clinical evaluation of drugs

Specialization / Direction

The aim of the course is to provide the necessary knowledge on topics related to preclinical and clinical evaluation of pharmaceuticals. Through this course the postgraduate students will learn to design and evaluate preclinical and clinical study protocols and their results.

1.Biopharmaceutical, Biopharmaceutical Classification System. Determination of biopharmaceutical properties. 2.Application of population pharmacokinetic models through the Simcyp platform in pharmaceutical research and development of new drugs 3.Development of new drugs: Pharmacological evaluation and applications, Drug administration and Pharmacogenomic approach 4.Bioavailability and basic pharmacokinetics, Bioequivalence studies and IVIVC 5.Design, Conduct and Evaluation of Bioequivalence Studies - Biowaiver Justification 6.Dissolution test. The concentration of active compound. Release rate is estimated according to the applicable specifications 7.Release profile of active pharmaceutical compounds from tablets / capsules: how solubilization method is developed, what are the defining characteristics, important parameters in the solubilization method, description of the requirements of the legislation for the method, importance of 3 pH release and how it can be used during storage, dissolution profile similarity between the drug under development and the prototype, by which methods can be demonstrated (f2 / multivariate confidence region / bootstrap f2), practical importance of release in relation to bioequivalence (examples of in vitro results in relation to in vivo), biorelevant dissolution media, in vitro in vivo correlation: a description of what it is and how it can be used 8.Good Clinical Practice (GCP)

19-01-2024