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005			20210303124343.0
008			080303s2009 njua b 001 0 eng
010			_a 2008009573
016	7		_a101467523 _2DNLM
020			_a9780470056097 (cloth)
020			_a0470056096 (cloth)
035			_a(OCoLC)213008102
040			_aDNLM/DLC _cDLC _dNLM _dBAKER _dBTCTA _dYDXCP _dC#P _dIXA _dDLC _erda
042			_apcc
050	0	0	_aRM301.8 _b.F67 2009
082	0	0	_a615.1 _222 _bF.
245	0	0	_aFormulation and analytical development for low-dose oral drug products / _cedited by Jack Zheng, pharmaceutical Sciences R&D, Lilly Research Labs, Eli Lilly and company
264		1	_aHoboken, N.J. : _bJohn Wiley & Sons, _c[2009]
264		4	_c©2009
300			_axxiii, 461 pages : _billustartions ; _c25 cm
336			_2rdacontent _atext
337			_2rdamedia _aunmediated
338			_2rdacarrier _avolume
504			_aIncludes bibliographical references and index.
505	0		_aAn overview / Jack Y. Zheng -- Challenges and strategies in formulation development of oral solid low-dose drug products / Jack Y. Zheng -- Particle size of drug substance and product content uniformity: theoretical considerations / Kevin C. Johnson -- Development of low-dose formulations using fluidized bed granulation / J. Joe Zhou, and Ralph Lipp -- Development of low-dose solid oral formulations using wet granulation / Ahmad Almaya -- Challenges in development and scale-up of low dose drug products by dry granulation: a case study / Mary T. Am Ende ... [et al.] -- Development of low-dose solid oral tablets using direct compression / Jack Y. Zheng and Robert L. Ternik -- Reduction of particle size of drug substance for low-dose drug products / Christopher L. Burcham ... [et al.] -- Function, quality, and regulations of pharmaceutical excipients for oral solid dosage forms / Jack Y. Zheng --
505	0		_aAnalytical method development: challenges and solutions for low-dose oral dosage forms / Beverly Nickerson ... [et al.] -- In vitro dissolution testing and method development / Vivian A. Gray, Jack Y. Zheng, and Norman N. Sesi -- Analysis of physical transformation of API during manufacture and storage / Gregory A. Stephenson -- Physical characterization tests for drug substances used in low-dose formulations / Ronald G. Lacocca -- An excipient library approach to analytical development for low-dose, solid oral dosage form drug products / Qing Chang ... [et al.] -- Cleaning verification for highly potent compounds / Brian W. Pack -- Containment challenges and strategies for potent compounds in the pharmaceutical industry / Victoria Cathcart, Sarah Jones, Beverly Nickerson -- Sample handling and containment in analytical testing laboratories / David Pattavina, Nancy Sage, Beverly Nickerson -- Regulatory considerations in the development of low-dose solid oral drug products / Ravi S. Harapanhalli.
650		0	_aDrugs _xDose-response relationship.
650		0	_aDrugs _xDosage.
650		0	_aOral medication.
650		0	_aDrug development.
650	1	2	_aChemistry, Pharmaceutical _xmethods.
650	2	2	_aAdministration, Oral.
650	2	2	_aDrug Evaluation, Preclinical _xmethods.
650	2	2	_aDrug Industry.
700	1		_aZheng, Jack. _eeditor.
856	4	2	_3Publisher description _uhttp://www.loc.gov/catdir/enhancements/fy0827/2008009573-d.html
856	4	1	_3Table of contents only _uhttp://www.loc.gov/catdir/enhancements/fy0827/2008009573-t.html
906			_a7 _bcbc _corignew _d1 _eecip _f20 _gy-gencatlg
942			_2ddc _cBK