ECTS credits ECTS credits: 3
ECTS Hours Rules/Memories Student's work ECTS: 51 Hours of tutorials: 3 Expository Class: 9 Interactive Classroom: 12 Total: 75
Use languages Spanish, Galician
Type: Ordinary subject Master’s Degree RD 1393/2007 - 822/2021
Departments: Pharmacology, Pharmacy and Pharmaceutical Technology
Areas: Pharmacy and Pharmaceutical Technology
Center Faculty of Pharmacy
Call: First Semester
Teaching: With teaching
Enrolment: Enrollable | 1st year (Yes)
- To provide an overview of the variables that play a role in the bioavailability of drugs once incorporated to dosage forms, particularly those intended for oral administration.
- To describe the evaluation procedures for testing drug solubility and permeability.
- To present the basis of the Biopharmaceutical Classification System (BCS) and to discuss its interest for the development and registration of new medicines.
- To give an account of the procedures useful to improve the position of a drug in the BCS.
Thematic block I. Bioavailability: solubility and permeability as key factors. Bioavailability evaluation.
Thematic block 2. Procedures for testing drug solubility and permeability: in silico, in vitro, ex vivo and in vivo approaches.
Thematic block 3. The Biopharmaceutical Classification System (BCS): basis, structure and usefulness during drug development. Regulatory issues. Incorporation of drug metabolism criteria: BDDCS (Biopharmaceutical Drug Disposition Classification System).
Thematic block 4. Approaches to improve drug solubility and permeability.
Amidon G.L., Lennernäs H., Shah V.P. y Crison J.R. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm. Res. 12, 413-420, 1995.
Amidon G.L. Rationale of a biopharmaceutics classification system (BCS) for new drug regulation. En: Choe S.Y. y Amidon G.L., editores. Capsugel Library-CDROM demo version. TSRL, Inc., 2000.
EMEA. Note for guidance on the investigation of bioavailability and bioequivalence
(http://www.emea.europa.eu/pdfs/human/ewp/140198en.pdf) 2001
EMEA. Concept paper on BCS-based biowaiver (http://www.emea.europa.eu/pdfs/human/ewp/21303507en.pdf) 2007.
EMEA. Guideline on the investigation of bioequivalence. (http://www.emea.europa.eu/pdfs/human/qwp/140198enrev1.pdf) 2008.
FDA. Guidance for industry. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. CDER, agosto 2000.
http://www.fda.gov/cder/guidance/index.htm
Loftsson C. Cyclodextrins and the biopharmaceutics classification system of drugs. J. Inclusion Phenom. Macrocyclic Chem. 44, 63-67, 2002.
Martinez M., Augsburger L., Johnston T. y Jones W.W. Applying the biopharmaceutics classification system to veterinary pharmaceutical products. Part I: biopharmaceutics and formulation considerations. Adv. Drug Del. Rev. 54, 805-824, 2002.
Martinez M., Augsburger L., Johnston T. y Jones W.W. Applying the biopharmaceutics classification system to veterinary pharmaceutical products. Part II: physiological considerations. Adv. Drug Del. Rev. 54, 805-824, 2002.
Van der Bijl P. y Van Eyk A.D. Comparative in vitro permeability of human vaginal, small intestinal and colonic mucosa. Int. J. Pharm. 261, 147-152, 2003.
Takagi T, Ramachandran C, Bermejo M, et al. A provisional biopharmaceutical classification of the top 200 oral drug products in the United States, Great Britain, Spain, and Japan. Molecular Pharmaceutics 3, 631-643, 2006.
Ku MS. Use of the biopharmaceutical classification system in early drug development. AAPS Journal 10, 208-212, 2008.
Benet LZ, Amidon GL, Barends DM, et al. The use of BDDCS in classifying the permeability of marketed drugs. Pharm. Res. 25, 483-488, 2008.
Karalis V, Macheras P, Van Peer A, et al. Bioavailability and Bioequivalence: Focus on physiological factors and variability. Pharm. Res. 25, 1956-1962, 2008.
- To understand the regulatory issues related to drug bioavailability and the relevance of the position of a drug in the BCS when application for new medicine registration.
- To understand the role that solubility and permeability play on drug bioavailability and to acquire skills to classify drugs in the BCS.
- To acquire ability to measure solubility and permeability.
- To acquire skills in the selection of approaches to solubilize drugs and to increase their permeability.
Lectures, interactive seminars and practical sessions of compulsory attendance.
Scenario 1: Attendance at lectures and work done in practical classes and seminars (50%), and final test consisting in solving case studies related to the subject (50%).
Scenario 2: The evaluation will consist of the completion of a non-face-to-face final test that will account for 50% of the final grade and the remaining 50% corresponds to a continuous evaluation carried out during the interactive classes and practical classes.
Scenario 3: The evaluation will consist of the completion of a non-face-to-face final test that will account for 50% of the final grade and the remaining 50% corresponds to a continuous evaluation carried out during the interactive classes and the different activities that they replace the practical classes.
Scenarios 2 and 3 will require the adoption of a series of measures that will require that the students have a device with a microphone and a camera while they do not have adequate assessment software. Students may be required for an interview to comment or explain part or all of the test. In cases of fraudulent performance of exercises or tests, the provisions of the Regulations for the evaluation of student academic performance and review of grades will apply.
Total ECTS credits: 3, distributed as follows:
- Theory (Assistance to lectures on thematic blocks): Class hours: 15; hours of student personal work: 22.5. 1.5 ECTS credits.
- Practice (access to databases, consultation and discussion of AGEMED and EMA documents) Class hours:
8; hours of student personal work: 12. 0.8 ECTS credits.
- Other activities: Preparation of material for seminars: hours of student personal work: 7.5. Presentations:
hours of class: 5. 0.5 ECTS credits.
- Evaluation (Preparation and resolution of the exam). Class hours: 2; hours of student personal work: 3. 0.2 ECTS credits
Basic knowledge of English and managing software.
Para los casos de realización fraudulenta de ejercicios o pruebas, se aplicará lo establecido en el Reglamento para la evaluación del desempeño académico de los estudiantes y la revisión de calificaciones.
Francisco Javier Otero Espinar
Coordinador/a- Department
- Pharmacology, Pharmacy and Pharmaceutical Technology
- Area
- Pharmacy and Pharmaceutical Technology
- Phone
- 881814878
- francisco.otero [at] usc.es
- Category
- Professor: University Professor
Iria Seoane Viaño
- Department
- Pharmacology, Pharmacy and Pharmaceutical Technology
- Area
- Pharmacy and Pharmaceutical Technology
- i.seoane.viano [at] usc.es
- Category
- Xunta Post-doctoral Contract
| Monday | |||
|---|---|---|---|
| 16:30-18:30 | Grupo 1/CLE_01 | Spanish | BROMATOLOGY SEMINAR ROOM 3 |
| 18:30-19:30 | Grupo 1/CLIS_01 | Spanish | BROMATOLOGY SEMINAR ROOM 3 |
| Tuesday | |||
| 16:30-18:30 | Grupo 1/CLE_01 | Spanish | BROMATOLOGY SEMINAR ROOM 3 |
| 18:30-19:30 | Grupo 1/CLIS_01 | Spanish | BROMATOLOGY SEMINAR ROOM 3 |
| Wednesday | |||
| 16:30-18:30 | Grupo 1/CLE_01 | Spanish | BROMATOLOGY SEMINAR ROOM 3 |
| 18:30-19:30 | Grupo 1/CLIS_01 | Spanish | BROMATOLOGY SEMINAR ROOM 3 |
| Thursday | |||
| 16:30-18:30 | Grupo 1/CLE_01 | Spanish | BROMATOLOGY SEMINAR ROOM 3 |
| 18:30-19:30 | Grupo 1/CLIS_01 | Spanish | BROMATOLOGY SEMINAR ROOM 3 |
| Friday | |||
| 16:30-17:30 | Grupo 1/CLE_01 | Spanish | BROMATOLOGY SEMINAR ROOM 3 |
| 17:30-19:30 | Grupo 1/CLIS_01 | Spanish | BROMATOLOGY SEMINAR ROOM 3 |