000			03774cam a2200565Ii 4500
001			9780429155352
003			FlBoTFG
005			20220509193122.0
006			m o d
007			cr cnu|||unuuu
008			190718t20202020flu ob 001 0 eng d
040			_aOCoLC-P _beng _erda _epn _cOCoLC-P
020			_a9780429155352 _q(electronic bk.)
020			_a0429155352 _q(electronic bk.)
020			_a9780429546938 _q(electronic bk. : Mobipocket)
020			_a0429546939 _q(electronic bk. : Mobipocket)
020			_a9781498769808 _q(electronic bk. : PDF)
020			_a1498769802 _q(electronic bk. : PDF)
020			_a9780429532238 _q(electronic bk. : EPUB)
020			_a0429532237 _q(electronic bk. : EPUB)
020			_z9781498769792
035			_a(OCoLC)1109390066
035			_a(OCoLC-P)1109390066
050		4	_aRS57
072		7	_aMAT _x029000 _2bisacsh
072		7	_aMED _x071000 _2bisacsh
072		7	_aMED _x090000 _2bisacsh
072		7	_aPBT _2bicssc
082	0	4	_a615.1/401513 _223
100	1		_aPitman, Arkadiy, _eauthor.
245	1	0	_aMathematical and statistical skills in the biopharmaceutical industry : _ba pragmatic approach / _cby Arkadiy Pitman, Oleksandr Sverdlov and L. Bruce Pearce.
264		1	_aBoca Raton, FL : _bCRC Press, Taylor & Francis, _c[2020]
264		4	_c©2020
300			_a1 online resource.
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
490	1		_aChapman & Hall/CRC biostatistics series
520			_aMathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach describes a philosophy of efficient problem solving showcased using examples pertinent to the biostatistics function in clinical drug development. It was written to share a quintessence of the authors' experiences acquired during many years of relevant work in the biopharmaceutical industry. The book will be useful will be useful for biopharmaceutical industry statisticians at different seniority levels and for graduate students who consider a biostatistics-related career in this industry. Features: Describes a system of principles for pragmatic problem solving in clinical drug development. Discusses differences in the work of a biostatistician in small pharma and big pharma. Explains the importance/relevance of statistical programming and data management for biostatistics and necessity for integration on various levels. Describes some useful statistical background that can be capitalized upon in the drug development enterprise. Explains some hot topics and current trends in biostatistics in simple, non-technical terms. Discusses incompleteness of any system of standard operating procedures, rules and regulations. Provides a classification of scoring systems and proposes a novel approach for evaluation of the safety outcome for a completed randomized clinical trial. Presents applications of the problem solving philosophy in a highly problematic transfusion field where many investigational compounds have failed. Discusses realistic planning of open-ended projects.
588			_aOCLC-licensed vendor bibliographic record.
650		0	_aPharmacy _xStatistical methods.
650		0	_aPharmaceutical industry _xStatistical methods.
650		0	_aDrugs _xTesting _xStatistical methods.
650		7	_aMATHEMATICS / Probability & Statistics / General _2bisacsh
650		7	_aMEDICAL / Pharmacology _2bisacsh
650		7	_aMEDICAL / Biostatistics _2bisacsh
700	1		_aSverdlov, Oleksandr, _eauthor.
700	1		_aPearce, Bruce L., _eauthor.
856	4	0	_3Taylor & Francis _uhttps://www.taylorfrancis.com/books/9780429155352
856	4	2	_3OCLC metadata license agreement _uhttp://www.oclc.org/content/dam/oclc/forms/terms/vbrl-201703.pdf
999			_c130283 _d130283