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100	1		_aNiazi, Sarfaraz K. _eauthor. _938250
245	1	0	_aBiosimilars development strategies : _bfast to market approaches / _cby Sarfaraz K. Niazi. _hEnglish.
250			_a1st.
260			_aBoca Raton : _bCRC Press Taylor & Francis Group, _c2025.
300			_aviii, 187 p. ; _c24 cm.
336			_atext _btxt _2rdacontent _0http://id.loc.gov/vocabulary/contentTypes/txt
337			_acomputer _bc _2rdamedia _0http://id.loc.gov/vocabulary/mediaTypes/c
338			_aonline resource _bcr _2rdacarrier _0http://id.loc.gov/vocabulary/carriers/cr
365			_b120.00 _cPound
504			_aIncludes bibliographical references and index.
505	0		_aAll About Biosimilars -- Product Type and Selection Strategies -- Development Master Plan -- Optimization of Cost of Goods -- Strategic Understanding for Biosimilars Future -- Repurposing Biosimilars.
520			_a"After 18 years since the first biosimilar was approved, a lot has changed, from the regulatory guidelines to the stakeholder perceptions about the safety and efficacy of biosimilars. However, the development costs remain high, preventing faster entry into markets with more than 200 choices. Analyzing the regulatory filings of all approved biosimilars in the US and EU, a deep analysis of the scientific principles, and continuous challenges to the regulatory authorities have made it possible to plan the development on a fast track. This book teaches how to cut the current time and cost by more than 70%, based on the author's hands-on experience"-- Provided by publisher.
588			_aDescription based on print version record and CIP data provided by publisher.
650		2	_aBiosimilar Pharmaceuticals _938251
650		2	_aDrug Development _934167
650		2	_aDrug Design _938252
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776	1		_iPrint version _4http://id.loc.gov/entities/relationships/printversion _aNiazi, Sarfaraz, 1949- _tBiosimilars development strategies _bFirst edition _dBoca Raton: CRC Press, 2025 _w(DLC) 2024003717 _z9781032517018 _z9781032519586 _z9781003404637
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