What is a preformulation study? Describe theoretical aspects for determining solubility and permeability of drug and its application.
[6 marks]Explain effect of physical properties of drug like physical form, particle size and shape on formulation, stability and bioavailability.
[5 marks]Discuss various drug degradation pathways and discuss oxidation in detail.
[5 marks]Discuss the regulatory requirements for conduction of bio-equivalence studies.
[6 marks]Define prodrug. Give its applications for improving stability of drug.
[5 marks]Enlist excipients used in Solid dosage form. Explain in details about Cellulose derivatives.
[5 marks]Enumerate factors affecting gastro intestinal absorption. Discuss in detail effect of gastric empting time on drug absorption.
[6 marks]What do you mean by polymer? Write a note on polymers used in different dosage forms with examples.
[5 marks]Write a note on matrixing and bracketing in stability study.
[5 marks]Describe the effect of containers and closures on stability of pharmaceuticals.
[6 marks]Discuss the factors affecting on stability of the drug.
[5 marks]Explain various methods used for enhancement of bioavailability.
[5 marks]Define relative and absolute bioavailability. Discuss plasma level time studies for measurement of bioavailability.
[6 marks]What is bioequivalence? Write a short note on Latin-square cross-over design.
[5 marks]Define BCS and BDDCS. Discuss theory of dissolution. Q. 6 (a) Enumerate different types of transport mechanism. Explain facilitated transport in detail.
[6 marks]Discuss storage conditions for stability testing as per ICH guidelines.
[5 marks]Describe the influence of BBB and CSF barriers on distribution of drugs
[5 marks]Discuss Noyes Whitney equation for rate of dissolution. Discuss USP type II apparatus for dissolution.
[6 marks]Classify methods for dissolution profile comparison and discuss model independent method in brief.
[5 marks]What is the importance of protein binding of drugs? Describe tissue binding of drugs in detail.
[5 marks]