What is pilot plan study? Discuss objective and steps for pilot plan scale up study.
[6 marks]Write a detailed note on various level of changes in SUPAC guidelines.
[5 marks]Discuss platform technology for scale up techniques with appropriate examples.
[5 marks]Define IND. What information is to submitted with IND application? How can IND application be withdraw?
[6 marks]Justify role of biostatistics in Pharmaceutical product development
[5 marks]Discuss general consideration for space requirement for scale up techniques.
[5 marks]Describe the responsibility of regulatory affairs professionals
[6 marks]Mention the goals of NDA. Discuss the general requirements for filing NDA.
[5 marks]Describe the content and format of NDA.
[5 marks]Describe the organization and responsibilities of CDSCO.
[6 marks]Explain Regulatory requirements and approval procedures for New drug.
[5 marks]Write a note on Certificate of Pharmaceutical Product.
[5 marks]Explain benefits and key elements QbD.
[6 marks]Write short note on Six sigma as a tool for quality management.
[5 marks]Explain ISO 9000 series of quality systems standards for pharmaceutical product. Q. 6 (a) Give classification, advantage and disadvantages of technology transfer.
[6 marks]What is granularity? Discuss the consideration in the granularity of TT process?
[5 marks]What is SUPAC? Give SUPAC guidelines for modified release dosages form.
[5 marks]Compare the following:
[6 marks]Responsibilities of SU’s and RU’s
[ marks]Do’s and Don’t of TT agreements.
[ marks]Write in brief about APCTD and NRDC.
[5 marks]Explain the principles of technology transfer. Discuss the technical and regulatory gap assessment during the process.
[5 marks]