Handbook of bioequivalence testing
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| Main Author: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
New York, NY
Informa Healthcare
2007
|
| Series: | Drugs and the pharmaceutical sciences
v.171 |
| Subjects: | |
| Tags: |
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| Call Number : | ref med QV 38 .N53 2007 |
MARC
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| 008 | 130401 2007 nyua bfi 000 0 eng d | ||
| 020 | |a 9780849303951(hardcover : alk.paper) | ||
| 020 | |a 0849303958(hardcover : alk.paper) | ||
| 039 | 9 | |a 201308011100 |b zul |c 201304011449 |d azraai |c 200911181404 |d VLOAD |c 200911181221 |d VLOAD |y 200910091815 |z VLOAD | |
| 040 | |a UPNM | ||
| 060 | |a QV 38 |b .N53 2007 | ||
| 090 | |a ref med QV 38 |b .N53 2007 | ||
| 100 | 1 | |a Niazi, Sarfaraz K. | |
| 245 | 1 | 0 | |a Handbook of bioequivalence testing |c Sarfaraz K. Niazi |
| 260 | |a New York, NY |b Informa Healthcare |c 2007 | ||
| 300 | |a xiv, 569 p. |b ill. |c 26 cm. | ||
| 490 | 1 | |a Drugs and the pharmaceutical sciences |v v.171 | |
| 504 | |a Includes bibliographical references and index | ||
| 505 | |a 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. | ||
| 591 | |a 0000006804 |b 10/12/08 |c 0200-07 |d 1 |e RM924 |f 1 |g 924 |h INTRABAKTI SD.BHD. | ||
| 592 | |a IN04071 |b 30/03/09 |c RM783 |d 1 |e 783 | ||
| 650 | 0 | |a Drugs |x Therapeutic equivalency |x Handbooks, manuals, etc | |
| 650 | 0 | |a Therapeutic equivalency |z United States | |
| 650 | 2 | |a Drug Approval |z United States | |
| 650 | 2 | |a Models, Stastical |z United States | |
| 830 | 0 | |a Drugs and the pharmaceutical sciences |v v.171 | |
| 999 | |a vtls000038826 |c 28304 |d 28304 | ||