Biopharmacy
1705-F5-BIOF-J
Biopharmacy as a subject brings the knowledge and skills that are essential to understanding the factors that have an impact on bioavailability of pharmaceutical preparation and releasing an active ingredient from drugs medicinal product.
The aim of lectures is to obtain a knowledge on releasing a drug’s active ingredient and its fate in organism based on pharmaceutical preparations. Biological membranes and physiological barriers are also a subject of interest.
The aim of the lectures is to introduce to the students the idea of bioavailability and its parameters as well as an impact of product form, route of drug administration, physiological factors and physicochemical properties of active ingredients and excipients on bioavailability.
Students are provided with a knowledge on interaction of medications with food and alcohol. Biopharmacy lectures are dedicated to discussing the research data according the availability of therapeutic drug ingredient as well as factors that affect the pharmaceutical availability and the methods of assessing profiles of therapeutic substance releasing. The problems of generic drugs and targeted pharmacotherapy are also presented during these lectures.
Laboratory class topics are to some extent bond with problems presented during lectures.
Lab class has a practical character, so their aim is to introduce students to analytical procedures and techniques essential for carrying out the particular research problem. They are designed as a student competence self-development by working with apparatuses designed to asset the rate of releasing therapeutic substance from a drug using techniques of high-performance liquid chromatography and spectroscopy. There are also used computer programs that allow to conduct sophisticated calculations based on data gathered during the class.
Laboratory classes allow to develop competences of effective teamwork and to specify conclusions based on conducted measurements and observations.
Total student workload
1. Obligatory hours realized with the teacher participation
- Lectures participation – 15 hours
- Tutorials participation – 45 hours
- Consultations participation – 2 hours
- Final test participation – 2 hours
Total obligatory hours realized with the teacher participation: 64 hours, which corresponds to 2.13 ECTS points.
2. Student workload balance:
- Lectures participation – 15 hours
- Tutorials participation – 45 hours
- Preparation for laboratories – 5 hours
- Reading the indicated literature – 6 hours
- Preparation of lab reports – 5 hours
- Consultations participation – 2 hours
- Final test preparation and test participation – 10 + 2 = 12 hours
A total work amount: 90 hours, which corresponds to 3 ECTS points.
3. Workload related to conducting research:
- Reading scientific literature – 4 hours
- Research and scientific consultation participation – 1 hour.
- Lectures (including methodology of research, results, and reports) participation – 10 hours
- Laboratory (including methodology of research, results, and reports) participation – 25 hours
- Preparation for laboratory that includes scientific activity – 3 hours
- Preparation for final test that includes scientific and research activity in the field of biopharmacy – 6 hours
- Preparation of laboratory course report on scientific research in biopharmacy – 5 hours
A total work amount of scientific research activity: 54 hours, which corresponds to 1.8 ECTS points.
4. Time required for the preparation and participation in evaluating process:
- Preparation for laboratory class + preparation for final test + final test: 5 + 10 + 2 = 17 hours (0.57 ECTS points)
5. Time required for the practical training completion – not applicable
Learning outcomes - knowledge
W1: Explains the structure of physiological barriers and their functions in the mechanisms of passage of drugs - K_D.W2
W2: Describes the fate of drug in the body and the pharmacokinetic processes to which the drug in the body is subject - K_D.W1, K_D.W3
W3: Uses the term of bioavailability and calculates parameters characterizing bioavailability and criteria for its assessment - K_D.W3, K_D.W9, K_D.W10
W4: Uses the term of pharmaceutical availability and calculates the parameters characterizing pharmaceutical availability and criteria for its assessment - K_D.W9, K_D.W10
W5: Interprets the impact of the drug form, route of administration, physicochemical properties of drug substances and excipients and physiological factors on the bioavailability of the drug substance and its duration of action - K_D.W9, K_D.W10
W6: Substantiates the correlation between drug release results obtained in vitro and bioavailability results determined in vivo (IVIVC) - K_D.W9
W7: Analyzes issues related to bioequivalence and organizes issues related to biopharmaceutical assessment of original and generic drugs - K_D.W11
W8: Predicts the interaction of drugs with food, stimulants and environmental pollution – K_D.W35, K_D.W7
Learning outcomes - skills
U1: Is able to determine the requirements for bioavailability and bioequivalence studies and use these studies to evaluate drugs - K_D.U4
U2: Is able to perform a pharmaceutical availability test under various conditions and for different forms of the drug and apply them to assess bioequivalence - K_D.U4, K_D.U7
U3: Is able to apply the BCS classification system in the process of releasing a medicinal product from in vivo bioequivalence studies - K_D.U8
U4: Is able to determine the effect of modification of the drug form on the pharmaceutical and biological availability of the drug substance - K_D.U4, K_D.U7, K_D.U9
U5: Is able to assess the effect of the composition of the drug, its form and physiological and pathological conditions on the absorption of the drug substance and advise on the proper application, dosage and intake of the drug - K_D.U1
U6: Is able to interpret and present scientific research on bioavailability, pharmaceutical availability and bioequivalence - K_D.U4, K_D.U5, K_D.U7
U7: Is able to perform a pharmaceutical availability test to assess the similarity of medicinal products using statistical analysis methods - K_D.U4, K_D.U7
U8: Is able to interpret the results of research on bioavailability, pharmaceutical availability and bioequivalence - K_D.U4, K_D.U5
Learning outcomes - social competencies
K1: Demonstrates the conclusions drawn from the measurements and observations made - K8
K2: Demonstrates the ability to work in a team – K3
Teaching methods
Lectures
A written test containing open and test questions: W1-W8, U1, U3 - U5.
Positive grades >60% of points.
Laboratories
A written test containing open questions : U1, U2, U4 - U8, W2 - W5, W8.
Positive grades >60% of points.
Properly conducting laboratory exercises and providing the reports on their results, continuous assessment of current preparation for classes and student activity: U8, K1, K2.
Grade:
92% - 100% - Excellent (5)
84% - 91% - Very good (4.5)
76% - 83% - Good (4)
68% - 75% - Satisfactory (3.5)
60% - 67% - Acceptable (3)
0% - 59% - Fail (2)
Obtaining credit for lectures and laboratory classes is a condition for passing the subject.
Final grade
The final grade is the average of the grades obtained:
4,75 - 5,00 Excellent (5)
4,25 - 4,74 Very good (4.5)
3,75 - 4,24 Good (4)
3,25 - 3,74 Satisfactory (3.5)
2,75 - 3,24 Acceptable (3)
0 - 2,74 Fail (2)
Type of course
compulsory course
Prerequisites
Basic information in the field of pharmacokinetics, pharmaceutical technology, biochemistry, phisicochemistry, biology, mathematics and statistics.
Course coordinators
Term 2022/23Z: | Term 2023/24Z: | Term 2025/26Z: | Term 2024/25Z: |
Assessment criteria
Lectures
A written test containing open and test questions: W1-W8, U1, U3 - U5.
Positive grades >60% of points.
Laboratories
A written test containing open questions : U1, U2, U4 - U8, W2 - W5, W8.
Positive grades >60% of points.
Properly conducting laboratory exercises and providing the reports on their results, continuous assessment of current preparation for classes and student activity: U8, K1, K2.
Grade:
92% - 100% - Excellent (5)
84% - 91% - Very good (4.5)
76% - 83% - Good (4)
68% - 75% - Satisfactory (3.5)
60% - 67% - Acceptable (3)
0% - 59% - Fail (2)
Obtaining credit for lectures and laboratory classes is a condition for passing the subject.
Final grade
The final grade is the average of the grades obtained:
4,75 - 5,00 Excellent (5)
4,25 - 4,74 Very good (4.5)
3,75 - 4,24 Good (4)
3,25 - 3,74 Satisfactory (3.5)
2,75 - 3,24 Acceptable (3)
0 - 2,74 Fail (2)
Practical placement
Not applicable according to the educational program
Bibliography
Primary literature:
1. Leon Shargel, Andrew B. C. Yu, Applied Biopharmaceutics & Pharmacokinetics, Seventh Edition, McGraw-Hill United States, 2016
2. Malcolm Rowland , Thomas N. Tozer, Clinical Pharmacokinetics and Pharmacodynamics : Concepts and Applications, Lippincott Williams and Wilkins, Philadelphia, 2010
3. Ashutosh Kar, Essentials of Biopharmaceutics and Pharmacokinetics- E-Book, Elsevier Health Sciences, 2010
4. Han van de Waterbeemd, Bernard Testa, Raimund Mannhold, Hugo Kubinyi, Gerd Folkers, Drug Bioavailability: Estimation of Solubility, Permeability, Absorption and Bioavailability, 2nd Edition, Wiley-VCH, 2008
5. Gopala Krishnamurty, Srinivasa Babu and Sheshagiri Rao, Pharmaceutical Statistics, PharmaMed Press, 2014
6. Ed.Milo Gibaldi, Biopharmaceutics and Clinical Pharmacokinetics,4th, PharmaMed Press, 2008
7. Recommended papers from scientific journals.
Supplementary literature:
1. Beverly McCabe-Sellers, Eric H. Frankel, Jonathan J. Wolfe, Handbook of Food-Drug Interactions, CRC Press, 2019
2. Thomas N. Tozer, Malcolm Rowland, Essentials of Pharmacokinetics and Pharmacodynamics, Lippincott Williams and Wilkins, Philadelphia, United States, 2015
3. Donald J. Birkett, Pocket Guide: Pharmacokinetics Made Easy, McGraw-Hill Education, Australia, 2011
Notes
Additional information
Additional information (registration calendar, class conductors,
localization and schedules of classes), might be available in the USOSweb system: