- Degree Bachelor
- Code: CCS041
- Credit hrs: 2
- Prequisites: CCS241
This course introduces students to the use of biological systems for the standardization and evaluation of pharmacologically active substances and medicinal products. It focuses on assessing pharmacological activity, potency, efficacy, and toxicity using appropriate biological assays and experimental models. Students study dose–response relationships, the principles of biological standardization, and the interpretation of experimental results in evaluating the strength and effects of drugs. The course also discusses efficacy studies for drugs acting on the central and autonomic nervous systems, cardiovascular system, and hormonal systems, as well as analgesic and anti-inflammatory agents. The practical component emphasizes the selection of suitable biological models, understanding experimental procedures, recording and interpreting data, comparing test preparations with reference standards, and applying laboratory safety and ethical principles. The course aims to develop students’ ability to evaluate pharmacological effects and contribute to the assessment of medicinal product quality, safety, and efficacy.
Bachelor of Pharmacy - PharmD (Clinical Pharmacy)
|
1.1 |
Explain the principles of biological assays used to evaluate the pharmacological activity, potency, efficacy, and toxicity of medicinal products. |
|
1.2 |
Describe dose–response relationships and the concepts of potency, efficacy, and safety in pharmacological standardization. |
|
1.3 |
Identify appropriate biological systems and assay methods for evaluating drugs acting on the central and autonomic nervous systems and cardiovascular system. |
|
1.4 |
Perform relevant calculations and interpret experimental data obtained from biological assays to estimate drug potency and compare test preparations with reference standards. |
|
1.5 |
Analyze and interpret experimental results from efficacy studies involving hormonal drugs, analgesics, and anti-inflammatory agents. |
|
1.6 |
Evaluate the pharmacological effects and potential toxicity of selected drugs using appropriate biological models and experimental endpoints. |
|
1.7 |
Explain the role of standardization and biological testing in assessing the quality, safety, and efficacy of medicinal products. |
|
1.8 |
Conduct or interpret basic pharmacological experiments using appropriate procedures, accurate data recording, and responsible laboratory practices. |
Rang, H. P., Dale, M. M., Ritter, J. M., Flower, R. J., and Henderson, G. Rang & Dale’s Pharmacology. Use the edition available through the institution.
| content serial | Description |
|---|
| 1 | Introduction to drug standardization; concepts of pharmacological activity, potency, efficacy, and safety (Lecture) |
| 1 | Introduction to laboratory procedures, safety requirements, and experimental documentation (Practical) |
| 2 | Principles and applications of biological assays; biological versus physicochemical methods (Lecture) |
| 2 | Identification of biological assay components and selection of suitable experimental models (Practical) |
| 3 | Dose–response relationships; graded and quantal responses (Lecture) |
| 3 | Construction and interpretation of dose–response curves using illustrative data (Practical) |
| 4 | Drug potency, efficacy, selectivity, and therapeutic index (Lecture) |
| 4 | Calculation and comparison of pharmacological potency and efficacy (Practical) |
| 5 | Standardization procedures, reference standards, and sources of experimental variability (Lecture) |
| 5 | Comparison of test preparations with reference standards using sample datasets (Practical) |
| 6 | Biological assays related to the central nervous system (Lecture) |
| 6 | Analysis of experimental endpoints used to evaluate selected central nervous system drugs (Practical) |
| 7 | Biological assays related to the autonomic nervous system (Lecture) |
| 7 | Interpretation of simulated or approved experimental data on autonomic drug responses (Practical) |
| 8 | Analysis of cardiovascular response data and assessment of relevant endpoints (Practical) |
| 8 | Analysis of cardiovascular response data and assessment of relevant endpoints (Practical) |
| 9 | Efficacy evaluation of hormonal drugs (Lecture) |
| 9 | Interpretation of hormonal drug assay results and comparison of responses (Practical) |
| 10 | Principles of analgesic drug evaluation (Lecture) |
| 10 | Analysis of analgesic efficacy data and comparison of test and reference preparations (Practical) |
| 11 | Principles of anti-inflammatory drug evaluation (Lecture) |
| 11 | Interpretation of anti-inflammatory efficacy data and experimental endpoints (Practical) |
| 12 | Toxicity assessment and safety endpoints in pharmacological testing (Lecture) |
| 12 | Evaluation of toxicity-related observations and identification of safety concerns using suitable datasets (Practical)) |
| 13 | Experimental design, controls, sources of error, and reproducibility (Lecture) |
| 13 | Review of experimental design, data quality, and common sources of error (Practical) |
| 14 | Statistical interpretation of biological assay results and reporting of findings (Lecture) |
| 14 | Data analysis, graphical presentation, and preparation of a brief experimental report (Practical) |
| 15 | Integrated review of biological standardization, efficacy, and safety assessment (Lecture) |
| 15 | Integrated practical exercise or case-based interpretation of pharmacological assay results (Practical) |
Start your application