000			01705nam a22002177a 4500
008			230307b2019 |||||||| |||| 00| 0 eng d
020			_a9781498750394
082			_a615.1097 NIA-S
100			_aNiazi, Sarfaraz K.
245			_aBiosimilarity : _bthe FDA perspective / _cSarfaraz K. Niazi
260			_aBoca Raton _bCRC Press _c2019
300			_a397 p.
365			_aGBP _b150.00. _N27.05.2023 _O17600 _L41917 _P23.05.2023 _cGreat Britain Pound _d150.00
500			_aSummary: The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory limits and non-inferiority testing are presented as tools to obviate patient trials and minimize testing of immunogenicity. An in-depth scientific, mathematical and statistical view of the tools required to establish biosimilarity of biological drugs of different complexity -- a must for every developer of biosimilars. Features: First comprehensive analysis based on new guidelines and approval packages of several biosimilars Presents the first approach to challenge FDA in reducing or eliminating any testing in patients. Provides a comprehensive understanding of the U.S. statutory requirements vis-a-vis the regulatory guidelines Provides model CQA and Analytical Similarity testing protocols for cytokines and monoclonal antibodies Allow creation of a fast-to-market pathway to develop biosimilars.
650			_aUnited States
650			_aPharmaceutical biotechnology
650			_aDrugs--Generic substitution
650			_aDrug approval
650			_aUnited States. Food and Drug Administration
650			_aGeneric drugs
999			_c90696 _d90696