The Science and Regulatory Perspectives of Pharmaceutical Suspensions Chapter

abstract

• AAPS 2010. All rights reserved. This chapter details the requirements of the U.S. Food and Drug Administration pertaining to suspension drug products. Extensive information is provided on nomenclature, regulatory filing requirements for new drug applications and abbreviated new drug applications, as well as postapproval changes and supplements. The global move to the common technical document format is also discussed. Finally, the authors present an overview of how quality by design principles can be effectively applied to suspension drug product technology.

authors

• Khan, Mansoor

author list (cited authors)

• Gupta, A., Sayeed, V. A., & Khan, M. A.

citation count

• 0

complete list of authors

• Gupta, Abhay||Sayeed, Vilayat A||Khan, Mansoor A

Book Title

• Pharmaceutical Suspensions

publication date

• January 2010

publisher

• Springer Nature  Publisher

keywords

• 36 Creative Arts And Writing
• 3602 Creative And Professional Writing
• 48 Law And Legal Studies
• Orphan Drug
• Rare Diseases

Digital Object Identifier (DOI)

• 10.1007/978-1-4419-1087-5_9

International Standard Book Number (ISBN) 13

• 9781441910868

start page

• 265

end page

• 283

URL

• http://dx.doi.org/10.1007/978-1-4419-1087-5_9