Define Quality by Design concept and explain its importance. How QbD is different from the conventional traditional approach?
[6 marks]Discuss the basic fundamentals of design of experimentation
[5 marks]Enlist different screening and optimization designs used in formulation development. Explain full factorial design giving a suitable example for factor and 3 level.
[2 marks]Discuss stability testing parameters for dosage forms tablets, capsules, emulsions, topical dosage form, metered dose inhalers and suppositories.
[6 marks]Which are the primary evaluation parameters needed to be studied as a part of a pre-formulation study in a pharmaceutical product development process.
[5 marks]What is the importance of solubility study in pharmaceutical product development process and how equilibrium solubility study is done?
[5 marks]Define: PAT, Design Space and QTTP.
[6 marks]Draw a flow chart describing formulation steps of any dosage form adopting the concept of quality by design.
[5 marks]How many types of stability studies are there and what is the importance of performing it during formulation development process?
[5 marks]Write a short note on plastics as a pharmaceutical packaging material.
[6 marks]Write in detail about the regulatory considerations for development of a pharmaceutical pack.
[5 marks]What should be the ideal content of a patient information leaflet and discuss it in order of its appearance?
[5 marks]Explain different formulation ingredients needed for preparing tablet dosage form by wet granulation method and discuss each category in detail with example.
[6 marks]Write a note on super-disintegrants.
[5 marks]Which different parameters are evaluated of hard gelatin capsule shell during its development? Q. 6 (a) Discuss cyclodextrins and its application in product development
[6 marks]Write a note on control release polymers used in pharmaceutical development process.
[5 marks]Classify semi-solid excipients and write in brief about them with example
[5 marks]What is CMA, CPP and CQA?
[6 marks]Importance of pre-formulation study in pharmaceutical development process
[5 marks]Write a note on placket-burman design.
[5 marks]