Latest Bioequivalence Stories

EXTON, Pa., April 30, 2013 /PRNewswire/ -- Absorption Systems, a global leader in preclinical contract testing of drugs, biologics, and medical devices, is pleased to announce that Vatsala Naageshwaran, Associate Director of Scientific Operations, will present a talk at the Disso 2013 Conference on May 3(rd) in Mumbai, India. The title of her presentation is "Permeability classification of highly variable drugs using the in vitro Caco-2 assay." The symposium, convened under the...

-Oxycodone DETERx® resistant to tampering via chewing and crushing CANTON, Mass., April 17, 2013 /PRNewswire/ -- Collegium Pharmaceutical, Inc., a specialty pharmaceutical company focused on the development of innovative treatments for chronic pain, today announced top-line results from its recently completed Phase I clinical trial for Oxycodone DETERx®, its extended-release, abuse-deterrent, multi-particulate product in a capsule form. The product utilizes Collegium's DETERx®...

Self-identifies as a Biopharmaceutics Classification System (BCS), Bioequivalence, and Bioavailability Testing Facility EXTON, Pa., March 25, 2013 /PRNewswire/ -- The preclinical contract research organization Absorption Systems, a global leader in pharmacokinetic testing of drugs and the world leader in the in-vitro classification of drugs according to the Biopharmaceutics Classification System (BCS), announces that it has registered with the United States Food and Drug...

CHAPEL HILL, N.C., Feb. 10, 2013 /PRNewswire/ -- The global generics drug market has grown substantially in previous years and is expected to see even more growth in the coming years. Given the rapid progress of the sector, organizations must critically manage and assess bioequivalence studies that are mandatory when bringing new generic drugs to market. Development, quality, cost and, speed are all vital success factors in the sector of generics. In order to help generics...

LUND, Sweden, December 3, 2012 /PRNewswire/ -- NeuroVive announces publication of the results of a Phase I clinical trial of lead product CicloMulsion(R) in the scientific journal Clinical Drug Investigation. The paper highlights that the intravenous cyclosporine formulation CicloMulsion(R) demonstrates bioequivalence and improved tolerability when compared with Sandimmune(R) Injection. The mitochondrial medicine company NeuroVive Pharmaceutical today announces...

PHILADELPHIA, June 23, 2012 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that on June 22, 2012, the US Food and Drug Administration (FDA) responded to Shire's Adderall XR citizen petition. The FDA's response requires that all abbreviated new drug applications (ANDAs) have to establish bioequivalence using partial area under the curve measurements at 5 hours and beyond 5 hours, for both d- and l- amphetamine. The...

CARY, N.C., June 20, 2012 /PRNewswire/ -- Cetero Research announced the completion of a major milestone in its reorganization efforts. Following the company filing for reorganization under Chapter 11 and the U.S. District Bankruptcy Court's approval of the sale of Cetero to its investor group, led by Freeport Financial, the sale of the company was finalized on June 20, 2012. (Photo: http://photos.prnewswire.com/prnh/20120620/PH27754 ) Over recent months, Cetero has engaged with...

CHADDS FORD, Pa., May 29, 2012 /PRNewswire/ -- Endo (Nasdaq: ENDP) announced today that it has reached an agreement with Watson Pharmaceuticals (Watson) resolving two patent infringement lawsuits related to LIDODERM (lidocaine patch 5%). A trial was held on the first of these cases in February 2012, and this resolution was reached prior to the Judge issuing a decision in the case. "We are pleased to have reached an agreement that protects Endo's intellectual property interests and...

Clinical Data on Grunenthal's Tamper Resistant Formulation Technology to be Presented at APS BEDMINSTER, N.J., May 15, 2012 /PRNewswire/ -- During this year's Annual Scientific Meeting of the American Pain Society (May 16-19, 2012 -- Honolulu, HI) Grunenthal will present results from clinical studies utilizing a product based on its INTAC(TM) formulation technology. INTAC(TM) is designed to be crush-resistant and to protect intended action of extended release drugs. Applying...

BOTHELL, Wash., April 19, 2012 /PRNewswire/ -- SCOLR Pharma, Inc. (OTCQB: SCLR) announced today that RedHill Biopharma Ltd., its license partner in developing an extended release version of the popular drug ondansetron (GlaxoSmithKline's brand name Zofran®), has reported successful results in a pivotal bioequivalence trial and intends to meet with the Food and Drug Administration to discuss an approval pathway. RedHill said its draft final report demonstrates that the trial met...