Blog http://www.absorption.com/r?19=960&32=16358&7=1004478&40=blog Blog rss feed en-us Fri, 17 May 2013 15:06:10 GMT 2013-05-17T15:06:10Z en-us Permeability Testing for Highly Variable Drugs http://www.absorption.com/r?19=961&43=984632&44=207870861&32=16358&7=1004478&40=http%3A%2F%2Fwww.absorption.com%2Fabsorb-this%2Fpermeability-testing-highly-variable-drugs.html The recent Disso India 2013 conference held in Mumbai, India on May 3rd and 4th attracted over 500 delegates and renowned speakers from all over the world. Fri, 17 May 2013 15:06:10 GMT 3b3fd7928a4a3b5ba81ba5f5ab4eb2df Vatsala Naageshwaran 2013-05-17T15:06:10Z Biosimilars? Biobetters? BLAs? FDA Pathway to Biosimilars Still Hazy http://www.absorption.com/r?19=961&43=984632&44=204724131&32=16358&7=1004478&40=http%3A%2F%2Fwww.absorption.com%2Fabsorb-this%2Fbiosimilars-biobetters-blas-fda-pathway.html While it is clear that extensive biochemical and biophysical characterization and comparison are necessary and that similarity can be demonstrated empirically at the molecular level, there can still be differences at the level of the bioassay or clinical results Thu, 25 Apr 2013 19:16:20 GMT 9217f5aa0098be87f126b301452eb7d6 Erica Weiskircher 2013-04-25T19:16:20Z Importance of MATEs in Drug-Drug Interaction (DDI) http://www.absorption.com/r?19=961&43=984632&44=201166201&32=16358&7=1004478&40=http%3A%2F%2Fwww.absorption.com%2Fabsorb-this%2Fmate-transporters-drug-drug-interaction-ddi.html One of the hottest topics was still the “new” transporter family, Multidrug and Toxin Extrusion (MATE) including MATE1 and MATE2-K, which have not been officially listed on the 2012 FDA Guidance for Industry and 2012 EMA Guideline on the Investigation of Drug Interactions. Wed, 03 Apr 2013 02:24:40 GMT 7384ffb4fbbed4cc06f10f2d83c4b236 Dr. Ying Wang 2013-04-03T02:24:40Z 2013 AAPS Workshop on Drug Transporters in ADME http://www.absorption.com/r?19=961&43=984632&44=200932101&32=16358&7=1004478&40=http%3A%2F%2Fwww.absorption.com%2Fabsorb-this%2F2013-aaps-workshop-drug-transporters-adme-bench-to-bedside.html Highlights from the 2013 AAPS Drug Transporter Workshop: From the Bench to the Bedside in Bethesda, Maryland March 16-23, 2013 Mon, 01 Apr 2013 20:45:25 GMT 57a1555d7908bd6330ba7e1c639a90b7 Lisa Murray 2013-04-01T20:45:25Z BCS, The Underutilized Pathway: Part 2 of 4 http://www.absorption.com/r?19=961&43=984632&44=191233191&32=16358&7=1004478&40=http%3A%2F%2Fwww.absorption.com%2Fabsorb-this%2Fbcs-biowaiver-pathway.html Biopharmaceutics Classification System (BCS) is a regulatory mechanism through which drug developers and generic companies can obtain a waiver of clinical bioequivalence studies, also called a biowaiver. Mon, 01 Apr 2013 17:48:42 GMT cc8536676f6820928bf1991c0f44fb37 Patrick Dentinger 2013-04-01T17:48:42Z BCS Biowaivers FDA Guidance Part 1 of 4 http://www.absorption.com/r?19=961&43=984632&44=189848971&32=16358&7=1004478&40=http%3A%2F%2Fwww.absorption.com%2Fabsorb-this%2FBCS-Biowaivers-FDA-Guidance-189848971.html If you know BCS, you are probably also aware of biowaivers. The FDA officially made the BCS part of the drug regulatory pathway by publishing a guidance in 2000. Mon, 01 Apr 2013 17:41:18 GMT 4d103a2ebe975c7e280b29ab65a27e4a Patrick Dentinger 2013-04-01T17:41:18Z BCS: Its Simple and Should Be Universal, Part 4 of 4 http://www.absorption.com/r?19=961&43=984632&44=200903591&32=16358&7=1004478&40=http%3A%2F%2Fwww.absorption.com%2Fabsorb-this%2Fbiopharmaceutics-bcs-based-drug-development-universal.html BCS Part 4 goes right to the core of 13 years of proven science. Did you know BCS-based testing may be your most cost-effective and ethical approach in drug development Mon, 01 Apr 2013 17:40:19 GMT fbed237ebd688356ed91f30de5f2dfe6 Patrick Dentinger 2013-04-01T17:40:19Z Ethical and Geopolitical Implications of the BCS: Part 3 of 4 http://www.absorption.com/r?19=961&43=984632&44=193144001&32=16358&7=1004478&40=http%3A%2F%2Fwww.absorption.com%2Fabsorb-this%2Fbiopharmaceutics-bcs-ethical-and-geopolitical-implications.html Biopharmaceutics Classification System (BCS). To improve access to many medications for these patients, the World Health Organization (WHO) has pushed strongly for the use of BCS-based criteria to classify a long list of drugs whose patents have expired, thereby making them eligible for manufacture by generic companies. Mon, 01 Apr 2013 17:39:49 GMT dbbdc9baca65ef4f34e12f9cc23951a0 Patrick Dentinger 2013-04-01T17:39:49Z MATE Drug Transporters Added to the FDA List http://www.absorption.com/r?19=961&43=984632&44=197816941&32=16358&7=1004478&40=http%3A%2F%2Fwww.absorption.com%2Fabsorb-this%2Fmate-drug-transporters-fda.html FDA’s CDER reviewers will now expect sponsors to evaluate proactively new drug candidates as substrates and/or inhibitors of the multidrug and toxin extrusion protein (MATE) family of renal efflux transporters (MATE1 and MATE2-K). Wed, 27 Mar 2013 19:43:18 GMT d27d2425f11b6daff371dc51a3e2653d Chris Bode 2013-03-27T19:43:18Z