Generic Drug Product Development: Specialty Dosage Forms explores the issues in providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. In addition, the book provides various scientific approaches and regulatory requirements for manufacturers to demonstrate the therapeutic...
In: Generic Drug Product Development: Bioequivalence Issues. Drugs and the Pharmaceutical Science. Edited by Kanfer I, Shargel L. CRC Press, Taylor & Francis Group, USA 2007, 180: 1 - 14.Verbeeck RK, Warlin J. The European Union, in Kanfer I, Shargel L (eds), Generic Drug Product ...
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Generic Drug Product Development: Bioequivalence Issues The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to th... I Kanfer,...
Finally, the future of generic drug product development and considerations to improve their regulation were discussed. More efforts will continue to enable a more efficient and rational generic drug product development and shortening of the review period for partial change approval. 展开 ...
“Our Abbreviated New Drug Application (ANDA) for Mycophenolate Mofetil for Oral Suspension received a first-cycle approval from the FDA, which underscores the quality of our filing, as well as our product development team,” saidTim Crew, chief executive officer of Lannett. “Moreover, this app...
FDA publishes PSGs to facilitate generic drug development by helping potential applicants efficiently allocate resources and prepare more complete submissions. Once these generic products are developed, approved, and marketed, generic competition for these drug products could ...
FDA Publishes New Product-Specific Guidelines for Generic Drug Development ByPharmaceutical Technology Editors February 17th 2023 EMA Recommends Five Medicines for Approval ByPharmaceutical Technology Editors December 23rd 2022 Generic-Drug Makers Also Fight Price Controls ...