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Study Guide 2019-20

DPHA_4 Preclinical and Clinical Drug Evaluation PDF Print

Instructors: E. Papadimitriou, G Patrinos, K. Poulas, G. Sivolapenko,G. Sotiropoulou S. Topouzis

Coordinator: S. Topouzis

Content:

Basic pharmacological and biochemical terms and definitions characterizing compound bioactivity (EC50, IC50, Km, etc).

Biochemical, immunological and immunochemical methods used to evaluate the activity of compounds in vitro.

In vitro cell-based and organoid-based models for the identification and evaluation of bioactive compounds.

Use of organs-on-a-chip in the preclinical evaluation of bioactive compounds.

In vivo experimental models used in the preclinical evaluation of bioactive compounds.

Regulatory framework of preclinical research in animals.

Preclinical data (ADMET) requirements for entering into clinical studies.

Regulatory framework of clinical drug development.

Regulatory processes and mechanisms of drug approval.

Regulatory framework for the approval of drugs with pharmacogenomic biomarker labeling (Companion Diagnostics).

Monitoring drug safety – Pharmacovigilence.