10.ConceptsinDrugMetabolism(intwoparts),editedbyPeterJenner andBernardTesta 11.PharmaceuticalAnalysis:ModernMethods(intwoparts),editedby JamesW.Munson 12.TechniquesofSolubilizationofDrugs,editedbySamuelH.Yalkowsky 13.OrphanDrugs,editedbyFredE.Karch
Shragel L, Kanfer I (2009) Generic drug product development: International regulatory requirements for bioequivalence. (1st Edn.), Informa Healthcare.Kanfer I, Shargel L (2008) Introduction-Bioequivalence issues, Generic Drug Product Development Bioequivalence Issues. Kanfer I, Shargel L, editors. ...
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...
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This article discusses the history and evolution of the process for generic drug evaluation and approval in the United States, with emphasis on locally act... JR Peters,DR Hixon,DP Conner,... - 《Dermatologic Therapy》 被引量: 52发表: 2009年 Evaluation of a kojic acid, emblica extract, an...
Once the recent guidances are finalized, they will highlight the FDA expectations for the development process of generic drug products that are equivalent to the specific drugs listed, including ADF opioids. Moving forward, the FDA plans to continue working to advance the development of generic ADF...
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,...
quality evaluations primarily investigate whether the key quality indexes of domestic generic drugs – such as dissolution and related substances – are consistent of those of reference preparations.If the quality is inconsistent, the drug manufacturer needs to re-develop the product formulation process....
US Food and Drug Administration (FDA). Accessed Feb 15, 2024 at https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity# Five branded generics strategies to master for pharmaceuticals in emerging markets. Accenture Consulting. Accessed Sept. 23,...
“We are elated to receive this grant and proud to collaborate with the FDA to help accelerate the drug development process of affordable generic medications,” said Rob Aspbury, Ph.D., President of Simcyp at Certara.“This project is aimed at further demons...