TY  - BOOK
AU  - Kanfer,Isadore
AU  - Shargel,Leon
TI  - Generic drug product development: bioequivalence issues 
SN  - 9780849377846 (hardcover : alk. paper)
AV  - RM301.45 .G42 2008
U1  - 615/.1 22
PY  - 2008///
CY  - New York
PB  - Informa Healthcare
KW  - Drugs
KW  - Therapeutic equivalency
KW  - Bioavailability
KW  - Generic drugs
KW  - Drugs, Generic
KW  - Biological Availability
KW  - Therapeutic Equivalency
N1  - Includes bibliographical references and index; Introduction-- bioequivalence issues / Isadore Kanfer and Leon Shargel -- Approved drug products with therapeutic equivalence evaluations (the orange book) / Loren Gelber -- Pharmaceutical alternatives : considerations for generic substitution / Roderick B. Walker, Roger K. Verbeeck, Isadore Kanfer -- Pharmacodynamic measurements for determination of bioequivalence / Manish Issar, Jeffrey G. Stark, and Leon Shargel --; Bioequivalence using clinical endpoint studies / Christopher Hendy -- Evaluation of bioequivalence of highly variable drugs / Laszlo Endrenyi and Laszlo Tothfalusi -- Statistical considerations: alternate designs and approaches for bioequivalence assessments / Stanford Bolton and Charles Bon --; Population pharmokinetic approaches for assessing bioequivalence / Philippe Colucci, Jean-Francois Marier, and Murray P. Ducharme -- Role of metabolites in bioequivalence assessent / André Jackson -- Implications of chirality for the assessment of bioequivalence / Reza Mehvar and Fakhreddin Jamali --; Effect of food on bioavailability and the assessment of bioequivalence / Kim Dalhoff and Isadore Kanfer -- Bioequivalence assessment of endogenous drug substances: pharmacokinetics and statistical evaluation / Philippe Colucci ... [et al.]
UR  - http://www.loc.gov/catdir/toc/ecip0727/2007039078.html
UR  - http://www.loc.gov/catdir/enhancements/fy0801/2007039078-d.html
ER  -