Course Information
Course Semester Plan
Course Information
| No | Module Name | Applied Biopharmaceutics and Clinical Pharmacokinetics |
| 1 | Code of Subjects | P12A.0105 |
| 2 | Study Load | 2 Credits |
| 3 | Semester | I |
| 4 | Precondition | There is no |
| 5 | Competence | After attending this lecture, students are able to create the design, protocol and bioavailability-bioequivalence study of a drug product in accordance with the applicable guidelines and regulations in Indonesia and MEA and evaluate drug therapy monitoring (TDM) activities in the clinic area. |
| 6 | Element of Competency | MKK |
| 7 | Type Competency | Supporting Competency |
| 8 | Course syllabus is about : | |
1. Biopharmaceutical Phases of drugs (Release, Dissolution and Absorption) 2. Physico-chemical, formulation and physiological-pathological factors on drug bioavailability 3. Biopharmaceutics Classification System (BCS) 4. IVIVC : In Vitro In Vivo Correlation 5. Ba-Be Test 6. Therapeutics Drug Monitoring 7. R&D Activities In A Pharmaceutical Industry 8. Bioequivalence Test: R&D Perspective 9. Bioequivalent Oral Solid Product Development: 10. R&D PERSPECTIVE (Case ) 11. Design and Determination of Drug Dosage Regiment and dose conversion 12. Pediatric and Geriatric Dosage Management 13. Dose Adjustment in Patients with Liver and Kidney Disease 14. Dosage Adjustments for Patients with Heart Disease, Obesity, and others |
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| 9 | Attribute Soft Skill | work in teams, statistical calculation |
| 10 | Learning Methods | collaborative learning, small group discussion, case study |
| 11 | Learning Media | LCD |
| 12 | Appraisal | Quiz 20%; Mid Assessment 30%; Final Assessment 30%; Soft Skill 20% |
| 13 | Lecturer | Taofik Rusdiana, M.Si., Ph.D., Apt, Eva Sumiyarni, Apt. Rovina, dr., SpPD., PhD. |
| 14 | References Required : | |
| Shargel, L and Yu, A., Applied Biopharmaceutics and Pharmacokinetics,7th ed., Appleton & Lange, 2017. Hartmut Derendorf Ph.D., 2019, Rowland and Tozer’s Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications, Wolters Kluwer Henry Cohen, 2014, Casebook in Clinical Pharmacokinetics and Drug Dosing-McGraw-Hill Medical Publishing P. Kaur, X. Jiang, J. Duan, E. Stier, Applications of in vitro–in vivo correlations in generic drug development: case studies, AAPS J., 17 (4) (2015), pp. 1035-1039 Larry Bauer, 2014, Applied Clinical Pharmacokinetics 3/E, McGraw-Hill Education / Medical William J Spruill; William E Wade; Joseph T DiPiro; Robert A Blouin; Jane M Pruemer, 2014, Concepts in clinical pharmacokinetics, American Society of Health-System Pharmacist |
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Course Semester Plan