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Hindi Journal of Pharmaceutical Sciences & Emerging DrugsISSN: 2380-9477
Kaiser J Aziz Author
Subjects of specialization
Affiliation
Pharmacology, Pharmaceutical Sciences, Medicinal Chemistry, Drag reduction, Drug Therapy
Department of Clinical Chemistry and Toxicology, Food and Drug Administration, Rockville, USA.
Biography
Kaiser J Aziz; Department of Clinical Chemistry and Toxicology, Food and Drug Administration, Rockville, USA. One of his references is, "Tesser JR, Furst DE, Jacobs I (2017) Biosimilars and the extrapolation of indications for inflammatory conditions. Biologics: Targets and Ther 11:5-11."
Publications
Review Article Open Access
Biosimilar Drug Development and Approval Process
Author(s): Kaiser J Aziz
The U.S. Food and Drug Administration (FDA) is responsible for advancing the public health by helping to review and evaluate biosimilar innovations that make medicines safer and more effective and by helping the public get the accurate, science-based information it needs to use medicines to maintain and improve public health. This presentation emphasizes quality system approaches to the development and availability of new drug information presented in the premarket applications. For approvals of biosimilars, the sponsors of premarket applications must present analytical characterization, pharmacokinetic (PK) and pharmacodynamic (PD) profiles, and comparative clinical studies to demonstrate that a proposed biosimilar is highly similar to a licensed reference product. It is recommended th... view more»
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