What are the critical stages in the pharmaceutical product development process?
[6 marks]Write a note on the different risk assessment tools.
[5 marks]Explain the ICH guidelines related to stability assessment of a dosage form
[5 marks]How screening designs and optimization designs differ? Explain the role of Plackett and Burman designs in pharmaceutical product development.
[6 marks]What is a mixture design? Explain its application
[5 marks]What is QbD? Explain the various elements of QbD.
[5 marks]Explain the role of Polyethylene Glycol and Sorbitol in Pharmaceutical formulation.
[6 marks]Discuss the role of cyclodextrins in the development of pharmaceutical products.
[5 marks]Describe non-ionic surfactants and their role in various pharmaceutical products.
[5 marks]Explain the enteric and non-enteric excipients used for tablet coating.
[6 marks]Explain the excipients used in preparation of pharmaceutical aerosols.
[5 marks]Discuss the criteria for the selection of excipient used for parenteral product development.
[5 marks]Discuss the advantages and disadvantages and selection criteria for using glass as a packaging material.
[6 marks]What factors should be considered when selecting a packaging material or system for a product?
[5 marks]Explain the formulation excipients of soft gelatin capsule Q. 6 (a) Write a note on mechanism of action and common binders and disintegrants used in tablet formulation.
[6 marks]Write a detailed note on diluents used in tablet formulation.
[5 marks]Write a note on excipients used in formulation of parenteral suspensions.
[5 marks]Explain factorial design with suitable example.
[6 marks]Explain in detail the different excipients use for formulation of NDDS.
[5 marks]Write a note on stability assessment of capsule dosage form.
[5 marks]