What is BCS classification? How does it affect the development of dosage form?
[6 marks]Define Half-life and Shelf life. Discus about international climatic zones as per ICH guideline
[5 marks]Define Bioequivalence. Explain the significance of Latin square cross over design.
[5 marks]Discuss the influence of container and closures on product stability.
[5 marks]Enlist various methods for measurement of bioavailability. Discuss any one in detail.
[6 marks]Discuss pH –Partition hypothesis along with its assumptions.
[5 marks]Write a short note on “Plasma Protein Binding”.
[5 marks]Discuss stability testing of new drug substances and products as per ICH guideline.
[6 marks]What are similarity factor and dissimilarity factor? How are they calculated and explain its significance.
[5 marks]Discuss the effect of containers and closures on stability of pharmaceuticals.
[5 marks]What is a Preformulation study? Describe theoretical aspects for determining solubility and permeability of drug and its application.
[6 marks]Discuss in detail volume of distribution.
[5 marks]Write a note on Biodegradable polymers.
[5 marks]Classify the polymers. Discuss in brief about polymer properties.
[6 marks]Define i) Bioavailability ii) Cmax iii) tmax iv) Overage v) Mean Kinetic Temperature
[5 marks]Write a note on drug clearance. Q. 6 (a) Define relative and absolute bioavailability. Discuss plasma level time studies for measurement of bioavailability.
[6 marks]Explain accelerated stability study as per ICH guidelines.
[5 marks]Enlist various transport mechanisms. Describe active transport as a mechanism for the passage of drug through biological membranes.
[6 marks]Explain USP dissolution apparatus III, IV and Vwith diagram.
[5 marks]Discuss Matrixing and Bracketing Techniques.
[5 marks]