Table of contents:
Introduction to FDA pre-NDA approval inspections; developing a strategic approach to preparing for a succesful pre-NDA approval inspection; international perspectives of a preapproval inspection; stability data and pre-approval inspections; successful management of a pre-approval inspection; the validation of pharmaceutical processes; preparaing for the pre-approval inspection through retrospective documentation; technology transfer and scale-up; training of personnel in the
Clarifies FDA requirements for the manufacture of clinical trial material as well as product development activities and suggests strategies that will facilitate FDA authorization to market.
Introduction to FDA pre-NDA approval inspections; developing a strategic approach to preparing for a succesful pre-NDA approval inspection; international perspectives of a preapproval inspection; stability data and pre-approval inspections; successful management of a pre-approval inspection; the validation of pharmaceutical processes; preparaing for the pre-approval inspection through retrospective documentation; technology transfer and scale-up; training of personnel in the
Clarifies FDA requirements for the manufacture of clinical trial material as well as product development activities and suggests strategies that will facilitate FDA authorization to market.