What is Preformulation? Discuss the significance of particle size and shape in formulation.
[6 marks]Explain the role of polymorphism and crystallinity in Preformulation. Enlist the methods to identify polymorphism.
[5 marks]Enlist the chemical properties observed during preformulation study. Explain oxidation and reduction in detail.
[5 marks]Classify the polymers. Discuss in brief about polymer properties.
[6 marks]Write a short note on “Plasma Protein Binding”.
[5 marks]Write a short note on Natural Gums.
[5 marks]Explain various methods used for enhancement of bioavailability.
[6 marks]Explain the role of Biopharmaceutics in formulation development.
[5 marks]Discuss the regulatory requirements for conduction of bio-equivalence Studies.
[5 marks]Write a note on factors affecting drug absorption.
[6 marks]Define i) Bioavailability ii) Cmax iii) tmax iv) Overage v) Mean Kinetic Temperature
[5 marks]What is IVIVC? Describe In-vitro -In-vivo correlations levels.
[5 marks]What is BCS classification? How does it affect development of dosage form?
[6 marks]Discuss Matrixing and Bracketing Techniques.
[5 marks]Effect of pKa and pH on absorption parameter. Q. 6 (a) Define Half-life and Self life. Discus about international climatic zones as per ICH guideline
[6 marks]Discuss the factors affecting stability of pharmaceutical formulation.
[5 marks]Discuss the effect of containers and closures on stability of pharmaceuticals.
[5 marks]Discuss stability testing of new drug substances and products as per ICH guideline.
[6 marks]Write a note on volume of distribution.
[6 marks]Storage conditions for stability testing as per ICH guidelines.
[6 marks]