Handbook of bioequivalence testing
by
Niazi, Sarfaraz, 1949-
Title
:
Handbook of bioequivalence testing
Author
:
Niazi, Sarfaraz, 1949-
ISBN
:
9780849383595
Publication Information
:
New York : Informa Healthcare USA, c2007.
Physical Description
:
xiv, 569 p. : ill.
Series
:
Drugs and the pharmaceutical sciences ; v. 171
Series Title
:
Drugs and the pharmaceutical sciences ; v. 171
Contents
:
Bioequivalence testing rationale and principles -- Regulatory aspect of bioequivalence testing -- Pharmacokinetic/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 validations -- Bioequivalence reports.
Subject Term
:
Drugs -- Therapeutic equivalency -- Handbooks, manuals, etc.
Electronic Access
:
Library | Material Type | Item Barcode | Shelf Number | [[missing key: search.ChildField.HOLDING]] | Status |
---|
Online Library | E-Book | 286609-1001 | ONLINE | | Elektronik Kütüphane |