Journal: Drug Invention Today

Article Id: JPRS-P'ceu-00005235
Title: Requirements of biopharmaceutics and clinical research for abbreviated new drug application submission – USA
Category: Pharmaceutics
Section: Review Article
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    The objective of the study is to understand the biopharmaceutic requirements for the submission of abbreviated new drug application (ANDA) for the United States Food and Drug Administration (USFDA), how to conduct the bioavailability/ bioequivalence (BE) studies, and how to submit those information to the agency, electronic common technical document structure for the dossier compilation, the significance of the BE to prove the rate and extent of the drug product is same as the branded drug product, this article also emphasizes on the FDA requirements for conducting the clinical studies. Generic drugs are the drugs, which are similar to the brand/reference listed product, not withstand the difference in strength, quality, dosage form, performance, route of administration, intended use, and characteristics. To get an approval from the USFDA for the marketing of generic drug, we need to file an ANDA. The BE can be achieved only if the rate and extent of absorption do not show a major difference from the reference listed drug (RLD), to demonstrate that the generic drug product is bioequivalent to the RLD all of the clinical study report data needed to be submitted in the module 5. Nowadays, more number of generic drugs are coming into the market; hence, the drug product will be available at the cheaper rate, but at the same time, the safety of the drug product is also very important; hence, the biopharmaceutics study is essential for the ANDA submission.

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  • About the authors and Affiliations

    Author(s) Name:

    B. C. Bharath, V. Balamuralidhara*, M. P. Venkatesh, M. P. Gowrav

    Affiliation(s) Name:

    Department of Pharmaceutics, Regulatory Affairs Group, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysore, Karnataka, India

    *Corresponding author: Dr. V. Balamuralidara, Department of Pharmaceutics, Regulatory Affairs Group, JSS College of Pharmacy, Sri Shivarathreeshwara Nagara, Mysore - 570 015, Karnataka, India.

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    Author:

    B. C. Bharath, V. Balamuralidhara*, M. P. Venkatesh, M. P. Gowrav

    Title:Requirements of biopharmaceutics and clinical research for abbreviated new drug application submission – USA
    Journal:Drug Invention Today
    Vol(issue):14 (April )
    Year:2020
    Page No: (1-6)
  • Experimental Methods Keywords

    Methodology:Requirements , Biopharmaceutics, Bioequivalence
    Research Materials: new drug application

Keywords

Abbreviated new drug application Biopharmaceutics Bioequivalence Reference listed drug

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