TY  - BOOK
AU  - Niazi,Sarfaraz
TI  - Handbook of bioequivalence testing
SN  - 9780849303951 (hardcover : alk. paper)
AV  - RM301.45 .N53 2007
U1  - 615.7 22
PY  - 2007///
CY  - New York
PB  - Informa Healthcare USA
KW  - Drugs
KW  - Therapeutic equivalency
KW  - Handbooks, manuals, etc
KW  - Therapeutic Equivalency
KW  - United States
KW  - Drug Approval
KW  - Models, Statistical
N1  - Includes bibliographical references and index; Bioequivalence testing rationale and principles -- Regulatory aspect of bioequivalence testing -- Pharmacokinetic and pharmacodynamic modeling -- Waiver of bioavailability/bioequivalence studies -- Regulatory review process -- Statistical evaluation of bioequivalence data -- Physicochemical properties affecting bioequivalence -- Drug delivery factors -- Bioanalytical method validation -- Good clinical practice -- Good laboratory practice for nonclinical laboratory studies -- Computer and software validation -- Bioequivalence reports
ER  -