Passive transdermal systems whitepaper incorporating current chemistry, manufacturing and controls (CMC) development principles

AAPS PharmSciTech

Volumn 13, Issue 1, 2012, Pages 218-230

  Van Buskirk, Glenn A ^a   Arsulowicz, Daniel ^b   Basu, Prabir ^c   Block, Lawrence ^d   Cai, Bing ^e   Cleary, Gary W ^f   Ghosh, Tapash ^e   González, Mario A ^g   Kanios, David ^h   Marques, Margareth ⁱ   Noonan, Patrick K ^j   Ocheltree, Terrance ^e   Schwarz, Peter ^k   Shah, Vinod ^l   Spencer, Thomas S ^m   Tavares, Lino ⁿ   Ulman, Katherine ^o   Uppoor, Rajendra ^e   Yeoh, Thean ^p  

^a Nonclinical Drug Development Consulting Services LLC   (United States)

^b Corium International Inc ^*  (United States)

^c National Institute of Pharmaceutical Technology and Engineering (NIPTE)   (United States)

^d DUQUESNE UNIVERSITY   (United States)

^e CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^f P'Kinetics International Inc ^*  (United States)

^g P'Kinetics International Inc   (United States)

^h Pharmaceutical Research Consultant   (United States)

ⁱ UNITED STATES PHARMACOPEIA   (United States)

^j Lohmann Therapie Systeme AG ^*  (United States)

^k LTS Lohmann Therapie Systeme AG   (Germany)

^l Pharmaceutical Consultant to USP   (United States)

^m Becwar Spencer Associates   (United States)

ⁿ PURDUE PHARMA L P   (United States)

^o DOW CORNING CORPORATION   (United States)

^p PFIZER INC   (United States)

more..

Author keywords

CMC; ICH; Quality by design (QbD); Residual drug; TDS

Indexed keywords

ADHESION; ARTICLE; DRUG COATING; DRUG DESIGN; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG MANUFACTURE; DRUG QUALITY; DRUG RELEASE; DRUG SCREENING; FLOW KINETICS; IN VITRO STUDY; IN VIVO STUDY; PARTICLE SIZE; PATIENT SAFETY; PRIORITY JOURNAL; SHEAR STRENGTH; TOTAL QUALITY MANAGEMENT; TRANSDERMAL DRUG ADMINISTRATION; VALIDATION PROCESS;

ADMINISTRATION, CUTANEOUS; ANIMALS; CHEMISTRY, PHARMACEUTICAL; DRUG DELIVERY SYSTEMS; DRUG DISCOVERY; DRUG INDUSTRY; EDUCATION; HUMANS; PHARMACEUTICAL PREPARATIONS;

EID: 84861093095     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-011-9740-9     Document Type: Article

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