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02106aam a2200385 a 4500 001 2749118EFC1E11E7B7150C4F97128E48 003 SILO 005 20180118010544 008 070314t20072007nyua bf 001 0 eng 010 $a 2007010944 020 $a 0849303958 020 $a 9780849303951 035 $a (OCoLC)86113099 040 $a DNLM/DLC $c DLC $d NLM $d BAKER $d BTCTA $d C#P $d YDXCP $d UKM $d UtOrBLW $d SILO 042 $a pcc 050 00 $a RM301.45 $b .N53 2007 060 10 $a W1 $b DR893B v.171 2007 060 10 $a QV 38 $b N577h 2007 082 00 $a 615/.7 $2 22 100 1 $a Niazi, Sarfaraz, $d 1949- $0 http://id.loc.gov/authorities/names/n79026149 245 10 $a Handbook of bioequivalence testing / $c Sarfaraz K. Niazi. 264 1 $a New York : $b Informa Healthcare USA, $c [2007] 300 $a xiv, 569 pages : $b illustrations ; $c 26 cm. 490 1 $a Drugs and the pharmaceutical sciences ; $v v. 171 504 $a Includes bibliographical references and index. 505 0 $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. 650 0 $a Drugs $x Therapeutic equivalency $v Handbooks, manuals, etc. 650 12 $a Therapeutic Equivalency. $2 [MeSH] $0 https://id.nlm.nih.gov/mesh/D013810 650 22 $a Drug Approval. $2 [MeSH] $0 https://id.nlm.nih.gov/mesh/D017277 650 22 $a Models, Statistical. $2 [MeSH] $0 https://id.nlm.nih.gov/mesh/D015233 651 2 $a United States. 830 0 $a Drugs and the pharmaceutical sciences ; $v v. 171. $0 http://id.loc.gov/authorities/names/n42009973 941 $a 1 952 $l OVUX522 $d 20180118014702.0 956 $a http://locator.silo.lib.ia.us/search.cgi?index_0=id&term_0=2749118EFC1E11E7B7150C4F97128E48Initiate Another SILO Locator Search