Scientific and Regulatory Considerations for Development and Commercialization of Poorly Water-Soluble Drugs

This chapter focuses on the Chemistry, Manufacturing, and Controls from the scientific and regulatory perspective of the development of poorly water-soluble drugs to provide insights into regulatory filing from Investigational New Drug Application to New Drug Application submission

Zedong Dong; Hasmukh Patel

2016

Scholarcy highlights

  • This chapter focuses on the Chemistry, Manufacturing, and Controls from the scientific and regulatory perspective of the development of poorly water-soluble drugs to provide insights into regulatory filing from Investigational New Drug Application to New Drug Application submission
  • The NDA section of the chapter includes the following: general regulatory filing requirements of an NDA application; potential regulatory issues associated with poorly water-soluble drugs; detailed discussions are carried out on topics including solid-form selection of the drug substance, drug product development using novel pharmaceutical technologies, development of control strategies, etc.; case studies of marketed drug products of poorly water-soluble drugs in various dosage forms; this part uses the public information of the approved products as examples to support the discussions as outlined in part; and brief discussion on the concept of Biopharmaceutics Classification System in the development of poorly soluble drugs
  • The book chapter concludes with a brief summary which emphasizes on the link between regulation and science

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