Summary workshop report: Biopharmaceutics classification system - Implementation challenges and extension opportunities

Journal of Pharmaceutical Sciences

Volumn 93, Issue 6, 2004, Pages 1375-1381

  Polli, James E ^a   Yu, Lawrence X ^b   Cook, Jack A ^c   Amidon, Gordon L ^d   Borchardt, Ronald T ^e   Burnside, Beth A ^f   Burton, Philip S ^g   Chen, Mei Ling ^b   Conner, Dale P ^b   Faustino, Patrick J ^b   Hawi, Amale A ^h   Hussain, Ajaz S ^b   Joshi, Hemant N ⁱ   Kwei, Gloria ^j   Lee, Vincent H L ^k   Lesko, Lawrence J ^b   Lipper, Robert A ^l   Loper, Alice E ^j   Nerurkar, Shiriniwas G ^b   Polli, Joseph W ^m   Sanvordeicer, Dilip R ⁿ   Taneja, Rajneesh ^o   Uppoor, Ramana S ^b   Vattikonda, Chandra S ⁱ   Wilding, Ian ^p   Zhang, Guohua ^q   more..

^a UNIVERSITY OF MARYLAND SCHOOL OF PHARMACY   (United States)

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

^c PFIZER INC   (United States)

^d UNIVERSITY OF MICHIGAN   (United States)

^e UNIVERSITY OF KANSAS   (United States)

^f Advancis Pharmaceutical Corporation   (United States)

^g ADMETRX   (United States)

^h A Hawi Consulting Ltd   (United States)

ⁱ Barr Laboratories   (United States)

^j MERCK RESEARCH LABORATORIES   (United States)

^k ALZA CORPORATION   (United States)

^l BRISTOL MYERS SQUIBB   (United States)

^m GLAXOSMITHKLINE   (United States)

ⁿ Watson Laboratories Inc   (United States)

^o TAP Pharmaceuticals   (United States)

^p PHARMACEUTICAL PROFILES LTD   (United Kingdom)

^q Watson Pharmaceuticals Inc   (United States)

more..

Author keywords

Bioequivalence; Biopharmaceutics Classification System (BCS); Oral absorption; Permeability; Regulatory science; Solubility

Indexed keywords

EXCIPIENT; UNCLASSIFIED DRUG;

ANALYTIC METHOD; BIOEQUIVALENCE; BIOPHARMACEUTICS CLASSIFICATION SYSTEM; CONFERENCE PAPER; DOSE RESPONSE; DRUG ABSORPTION; DRUG CLASSIFICATION; DRUG PENETRATION; DRUG SOLUBILITY; IN VITRO STUDY; INTESTINE TRANSIT TIME; PH MEASUREMENT; QUALITATIVE ANALYSIS;

EID: 2642530433     PISSN: 00223549     EISSN: None     Source Type: Journal    
DOI: 10.1002/jps.20064     Document Type: Conference Paper

References (1)

1. Guidance for industry, waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. August 2000, CDER/FDA (http://www.fda.gov/cder/guidance/3618fnl.htm).