Pharmaceutical analysis: supplements

Academic year: 2010-2011 Course code module 1MFAR-GO-006 Semester: 2nd semester Credits: 6 Study load (hours) 168 Theory (hours): 22,50 Practice/Exercises(hours): 40,00 Other (hours): 12,00 Part-time program: 2 Instructor(s) Sandra Apers Magda Claeys Paul Cos Adrian Covaci Nina Hermans Language of instruction: Dutch Semester exam information: exam in the 2nd semester Contract restriction information: exam contract not possible 1. Prerequisites *Algemene competenties Basic knowledge on analytical techniques, pharmaceutical analysis and statistics. *Sequentiality Pharmaceutical Analysis III (3BFAR-03) AND Introduction to Medicinal Chemistry and Drug Development (3BFAR-06) AND Pharmacognosis I : medicinal plants and natural products (3BFAR-021) AND Food and Nutrition Theory I (3BFAR-04) 2. Objectives (expected learning outcomes) The aim of the course is to gain knowledge on sample preparation methods, analytical techniques and materials used in specific area's. The students will be trained in quality control and validation. 3. Course content The course contains several parts. In the first part different techniques and procedures to prepare and clean up samples will be discussed. An overview of the different columns available for HPLC and GC is given. The second part deals with analysis in different field, e.g. toxicology, microbiology, bromatology and pharmacognosy. In the part on the registration file, the requirements on the analytical part are summed up. The last part of the course is dedicated to quality control and validation. Quality guidelines, field of application and evaluation services are discussed. Method validation is thought during the practical course and seminars. International guidelines on validation are discussed, equipment is checked and methods are validated. The results obtained are evaluated by means of statistics (Excel). 4. Teaching method Direct contact: Lectures Exercise sessions Seminars (possible question and answer sessions) Practical sessions Personal work: Excursion(s) 5. Assessment method Exam: Written, without oral presentation Closed book Open book Practical exam 6. Compulsory reading – study material course 7. Recommended reading - study material Websites European Pharmacopoeia - EMEA - kwaliteitsnormen - commerciële sites chromatografisch materiaal (links blackboard) 8. Tutoring Coördinaten docenten: S. Apers:                     e-mail: sandra.apers@ua.ac.be Tel :     03 820 27 20 M. Claeys:                   e-mail: magda.claeys@ua.ac.be P. Cos :                       e-mail : paul.cos@ua.ac.be Adrian Covaci :            e-mail : adrian.covaci@ua.ac.be N. Hermans:                e-mail: nina.hermans@ua.ac.be laatste aanpassing: last update: 16/02/2011 17:04 adrian.covaci