Explain preformulation studies. What is partition coefficient? What is its significance in preformulation?
[6 marks]Write a note on Prodrug. Discuss Prodrug approaches.
[5 marks]Write a note on polymorphism aspect of an API in relation to preformulation study.
[5 marks]Discuss physiological barriers to drug distribution in body.
[6 marks]Enumerate the drug transport mechanisms. Discuss passive diffusion in detail.
[5 marks]Explain plasma protein binding in detail.
[5 marks]What is the importance of an adjuvant in pharmaceutical products? Enlist cellulose derivatives polymers and write a note on HPMC.
[6 marks]Classify additives used in pharmaceutical formulations. Describe in detail about suspending agents.
[5 marks]Write a note on Biodegradable polymers.
[5 marks]Enumerate different factors affecting the stability of a dosage form and discuss each in brief.
[6 marks]Define overages and discuss methods to determine overages.
[5 marks]Explain accelerated stability study as per ICH guidelines.
[5 marks]Discuss remedies to overcome degradation due to hydrolysis and oxidation in pharmaceutical dosage form.
[6 marks]Classify the methods for bioavailability measurement. Discuss the method based on plasma data.
[5 marks]Enlist the theories of dissolution. Explain in detail Film Theory Q. 6 (a) What are similarity factor and dissimilarity factor, how are they calculated and give their significance.
[6 marks]Define absolute and relative bioavailability. Describe Latin Square cross over design for bioequivalence study.
[5 marks]Discuss the regulatory requirements for conduction of bioequivalence studies.
[5 marks]What is biorelevant dissolution media? Name the USP dissolution apparatus with the use.
[6 marks]What is BCS? Classify and give the significance of this system
[5 marks]Discuss in detail volume of distribution.
[5 marks]