Search Results for "Alfuzosin Modified Release Bioequivalence"
Original Source: Alfuzosin Hydrochloride [Golden State Medical Supply, Inc.]
Alfuzosin Hydrochloride Extended-Release Tablets, USP Initial U.S. Approval: 2003 These highlights do not include all the information needed to use alfuzosin hydrochloride extended-release tablets safely and effectively. See full prescribing information f
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Synthesis and Release of Thyroid Hormones
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Transgenic plants have been engineered to possess several desirable traits, such as resistance to pests, herbicides, or harsh environmental conditions, improved product shelf life, and increased nut...
Drug Delivery - news, views, blogs
Drug delivery is the method or process of administering a pharmaceutical compound to achieve a therapeutic effect in humans or animals. Drug delivery technologies are patent protected formulat...
Disorders of Calcium Concentration
Calcium (Ca) is required for the proper functioning of muscle contraction, nerve conduction, hormone release, and blood coagulation. In addition, proper Ca concentration is required for various othe...
Tumor antigen is an antigenic substance produced in tumor cells, i.e., it triggers an immune response in the host. Tumor antigens are useful in identifying tumor cells and are potential candidates f...
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The AAPS Journal: Metrics for the Evaluation of Bioequivalence of Modified-Release Formulations
Type: Original PaperMetrics are discussed which are used for the evaluation of bioequivalence of modified-release formulations. In order to ensure the therapeutic equivalence of the compared drug prod...
Wockhardt to Launch Generic Version of BPH Drug Uroxatral
Wockhardt has received final approval from the FDA for marketing 10mg extended release tablets of Alfuzosin hydrochloride, which is used in treatment of Benign Prostatic Hyperplasia or enlarged prosta...
Type: Brief CommunicationNo abstract available.
Type: Original PaperPurposeTo propose a simple method for the development of genipin-crosslinked casein micelles as a new delivery platform for prolonged release of alfuzosin hydrochloride.MethodsCros...
FDA Approving More ANDAs That Use Novel Bioequivalence Methods
OGD officials report on the progress being made in approving generic drugs using more novel and science-based bioequivalence methods than in the past. Officials impart tips on how to submit review-rea...
Generic Bupropion XL Reevaluation Running Behind Schedule
FDA has received data from just one of four bioequivalence studies of 300 mg bupropion extended-release generics it requested by March from sponsors following Impax/Teva’s withdrawal of their generi...
Generic Antiseizure Drugs Similar to Brand Names
The latest bioequivalence study shows that generic modified release products have similar plasma concentrations as their brand name reference products. Medscape Medical News
Type: ReportThis summary workshop report highlights presentations and over-arching themes from an October 2011 workshop. Discussions focused on best practices in the application of biopharmaceutics in...
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Metrics for the Evaluation of Bioequivalence of Modified-Release Formulations.
Metrics are discussed which are used for the evaluation of bioequivalence of modified-release formulations. In order to ensure the therapeutic equivalence of the compared drug products, it would be im...
PURPOSE: To propose a simple method for the development of genipin-crosslinked casein micelles as a new delivery platform for prolonged release of alfuzosin hydrochloride. METHODS: Crosslinked casein...
In the European Union multiple dose bioequivalence studies are required for the approval of generic prolonged-release products, but they are not required by the US-FDA. In order to investigate if the...
Use of Partial AUC to Demonstrate Bioequivalence of Zolpidem Tartrate Extended Release Formulations.
PURPOSE: FDA's bioequivalence recommendation for Zolpidem Tartrate Extended Release Tablets is the first to use partial AUC (pAUC) metrics for determining bioequivalence of modif...
