LEADER 02576nam 2200445 450 001 9910677052103321 005 20191111074841.0 010 $a1-118-67583-5 010 $a1-118-67577-0 010 $a1-118-67574-6 035 $a(CKB)4330000000006745 035 $a(MiAaPQ)EBC5940462 035 $a(PPN)243211341 035 $a(EXLCZ)994330000000006745 100 $a20191111d2020 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aIn vitro drug release testing of special dosage forms /$fedited by Nikoletta Fotaki, Sandra Klein 210 1$aHoboken, New Jersey ;$aChichester, West Sussex, England :$cWiley,$d[2020] 210 4$dİ2020 215 $a1 online resource (315 pages) 225 1 $aAdvances in pharmaceutical technology 311 $a1-118-34147-3 330 $a"In the mid 1960s people realized that drug dissolution/release has a significant impact on the therapeutic effect of orally administered drugs. Both the United States Food and Drug Administration (FDA) and United States Pharmacopoeia introduced dissolution requirements for oral drug products and the first dissolution tests became a quality control (QC) tool to ensure batch-to-batch consistency. As a consequence, from the 1970s on, several dissolution test methods were adopted as official QC methods for solid oral dosage forms. In the late 1990s, the increasing number of official dissolution apparatus and dissolution methods in the USP was complemented by the release of various FDA guidances pertaining to in vitro dissolution testing of solid oral dosage forms and its application from a regulatory point of view. Since then dissolution/drug release testing has expanded considerably with a variety of apparatus and methods in international pharmacopoeia and numerous international guidances and nowadays not only addresses questions of quality control but also plays an important role in screening of formulations and is also an important tool in proving bioequivalence of different drug products"--$cProvided by publisher. 410 0$aAdvances in pharmaceutical technology. 606 $aSolid dosage forms 615 0$aSolid dosage forms. 676 $a615.19 702 $aFotaki$b Nikoletta$f1973- 702 $aKlein$b Sandra$f1970- 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910677052103321 996 $aIn vitro drug release testing of special dosage forms$93068772 997 $aUNINA