After the completion of this course the student should be able, in a self directed manner, to discuss the:
- Physicochemical and biological factors affecting drug bioavailability, including drug absorption, distribution, metabolism, and excretion.
- Experimental models for assessing formulation effects on bioavailability (viz. in vitro, in situ, in vivo –models),.
- Assessment of bioavailability, bioequivalence testing, in vitro in vivo correlation, drug product selection and biopharmaceutical classification system2-Intended learning outcomes of course (ILOs):
- Knowledge and understanding
The student should be able to:
a1-Mention the fundamentals of biopharmaceutics, the effect of route of administration as well as type of drug delivery system on drugs bioavailability,
a2-Illustrate the design of bioavailability and bioequivalence studies, and assessment of biopharmaceutical parameters,
a3-Define the theoretical and practical concepts related to biopharmaceutics involved in drug dosage form design,
a4-Discuss the different methods of permeability assessment
a5-Enumerate the regulations for bioequivalence studies.
- Intellectual skills:
The student should be able to:
b1-Find and assess information quickly and reliably concerning biopharmaceutics.
b2-Judge the professional acceptance of generic drug products based on bioequivalence data
b3-Analyze, evaluate, interpret different biopharmaceutical, bioavailability, bioequivalence problems.
- Professional and practical skills
The student should be able to:
c1-Handle -in a creative way- complex issues related to bioavailability and bioequivalence studies
c2-Conduct standard bioavailability procedures and handling data in terms of graphical presentation and statistical analysis.
- General and transferable skills:
The student should be able to:
d1-Master on-line computer searching
d2- Be independent life long learner
d3- Work as a part of team in bioavailability and bioequivalence studies
d4- Plan and implement efficient and effective mode of working in biopharmaceutical studies.