Μ3. Preclinical and clinical drug evaluation
Purpose/Objectives of the Course
The following thematic units are developed in the course: Pharmacological evaluation and applications. Drug delivery and pharmacogenomics approach. Introduction to Biopharmaceutics. Biopharmaceutical Classification System, Determination of biopharmaceutical properties, Active ingredient release profile from tablets/capsules. Dissolution rate control. Bioavailability and basic pharmacokinetics. Design, – Biowaiver Justification. Bioequivalence and IVIVC studies. Ethical evaluation, preparation, organization, implementation and monitoring of experimental protocols. Good Clinical Practice (GCP).
Coordinator
| Image | Name | Designation | Contract Info | Social Links |
|---|---|---|---|---|
 |
Kachrimanis Kyriakos | Professor of Pharmaceutical Technology | kgk@pharm.auth.gr 2310997666 |
Teachers
| Image | Name | Designation | Contract Info | Social Links |
|---|---|---|---|---|
 |
Argyros Orestis | PhD | ||
 |
Barmpalexis Panagiotis | Associate Professor of Pharmaceutical Technology | pbarmp@pharm.auth.gr 2310997629 | |
|
|
Kachrimanis Kyriakos | Professor of Pharmaceutical Technology | kgk@pharm.auth.gr 2310997666 | |
 |
Kafkala Styliani | MSc | ||
 |
Papadopoulou Lefkothea | Professor of Pharmacology | lefkotea@pharm.auth.gr 2310997636 | |
 |
Paspaltsis Ioannis | PhD, EDIP, School of Pharmacy, AUTh | ||
 |
Patrinos George | Professor of Pharmacogenomics and Pharmaceutical Biotechnology | gpatrinos@upatras.gr 2610962339 | |
 |
Vizirianakis Ioannis | Associate Professor of Molecular Pharmacology and Pharmacogenomics | ivizir@pharm.auth.gr 2310997658 |
Teaching Assistants
| Image | Name | Designation | Contract Info | Social Links |
|---|---|---|---|---|
 |
Mystridis A. Georgios | MSc, MBA, c.PhD | geormyst@pharm.auth.gr |
Course Organization
ECTS: 8
Lectures: 8
PC application: 3
Workload
200 – 240 hours
Lectures/Workshops: 70 hours
Personal effort: 130 hours
Course Lectures
Week | Faculty | Teaching method | Description of teaching unit |
1 | Kahrimanis Kyriakos. Prof. of Pharm. Technology, AUTH | Theory | Biopharmaceuticals, Biopharmaceutical Classification System Determination of biopharmaceutical properties |
2 | Barbalexis Panagiotis Asst. Prof. of Pharm. Technology, AUTH | Theory | Bioavailability and basic pharmacokinetics |
3 | Barbalexis Panagiotis Asst. Prof. of Pharm. Technology, AUTH | Theory | Bioequivalence studies and IVIVC |
4 | Vizirianakis Ioannis, Asst. Professor of Pharmacology AUTH | Theory | Development of new drugs A: Pharmacological evaluation and applications |
5 | Vizirianakis Ioannis, Asst. Professor of Pharmacology AUTH | Theory | New Drug Development B: Drug Delivery and Pharmacogenomics Approach |
6 | Vizirianakis Ioannis, Asst. Professor of Pharmacology AUTH
Mystridis Georgios MSc, PhD candidate: licensed to use the Simcyp platform | P/C application | Application of population pharmacokinetic models through the Simcyp platform in pharmaceutical research. Development of new drugs (part I) |
7 | Vizirianakis Ioannis, Asst. Professor of Pharmacology AUTH
Mystridis Georgios MSc, PhD candidate: licensed to use the Simcyp platform | P/C application | Application of population pharmacokinetic models through the Simcyp platform in pharmaceutical research. Development of new drugs (part II) |
8 | Georgios Patrinos, Prof. of Pharmacogenomics and Pharmaceutical Biotechnology, Univ. Patras | Theory | Pharmacogenomics in the post-genomic era |
9 | Paspaltzis Ioannis MSc, PhD Pharmacology, EDIP, AUTH | Theory | Introductory concepts in biotechnology |
10 | Papadopoulou Lefkothea Professor of Pharmacology AUTH | Theory | “Pharmaceutical Biotechnology: Application of Protein Transduction Technology (PTD Technology) for the production of recombinant proteins in the context of therapeutic approach to monogenic-metabolic diseases Part I |
11 | Papadopoulou Lefkothea Professor of Pharmacology AUTH | Theory | “Pharmaceutical Biotechnology: Application of Protein Transduction Technology (PTD Technology) for the production of recombinant proteins in the context of therapeutic approach to monogenic-metabolic diseases Part IΙ |
12 | Papadopoulou Lefkothea Professor of Pharmacology AUTH | Lab | Antimicrobial chemotherapeutic drugs: method for determining the sensitivity and resistance of microorganisms to antibiotics (Antibiogram) |
13
| Kafkala Stella, MSc, cPhD, Analytical Development Director, Genepharm | Theory | API release profile from tablets/capsules |
14 | Exams/Theory | ||
Examination of the course
Final exam
Course Essays
Related Bibliography
PHARMACEUTICAL TECHNOLOGY, AULTON, DRUG DESIGN AND MANUFACTURE (4TH ED.)
Author: MICHAEL E. AULTON , KEVIN M.G. TAYLOR
Edited by: KYRIAKOS KACHRIMANIS, IOANNIS NIKOLAKAKIS
ISBN: 9789605832162
Link
