International Journal For Multidisciplinary Research

E-ISSN: 2582-2160   •   Impact Factor: 9.24

A Widely Indexed Open Access Peer Reviewed Multidisciplinary Bi-monthly Scholarly International Journal

Call for Paper Volume 6 Issue 6 November-December 2024 Submit your research before last 3 days of December to publish your research paper in the issue of November-December.
Submit Research Paper Join as a Reviewer

Plagiarism is checked by the leading plagiarism checker TurnItIn

Call for Paper

Volume 6 Issue 6
November-December 2024

Submit your research paper

Indexing Partners
Academia Advanced Sciences Index Bielefeld Academic Search Engine CiteSeer DRJI Google Scholar Independent Search Engine & Directory Network ISI (International Scientific Indexing) Issuu Mendeley Research Networks
RefSeek ResearcherId - Thomson Reuters ResearchGate Scirus Scribd Semantic Scholar UTeM - Universiti Teknikal Malaysia Melaka Wiki for Call for Papers WorldCat Zenodo

Patient Safety and Efficacy Considerations in Abbreviated New Drug Application (ANDA) Evaluation: Balancing Access and Regulation

Author(s) Samyukta D, Senthil Kumar N, Senthil Kumar B
Country India
Abstract The Abbreviated New Drug Application (ANDA) process is pivotal in facilitating the availability of generic drugs, offering cost-effective alternatives to branded medications while ensuring patient safety and therapeutic efficacy. This review delves into the critical considerations involved in ANDA evaluation, focusing on the regulatory balance required to maintain drug quality and accessibility. Key elements such as bioequivalence, therapeutic equivalence, and compliance with Good Manufacturing Practices (GMP) are scrutinized to highlight their roles in safeguarding patient outcomes. The review also addresses the challenges posed by evolving drug formulations, manufacturing technologies, and the increasing complexity of global supply chains. Additionally, it discusses the regulatory frameworks that guide ANDA approvals, emphasizing the importance of rigorous post-marketing surveillance to detect and mitigate potential safety issues. Through an analysis of recent case studies and regulatory updates, the review identifies best practices and suggests potential areas for improvement in the ANDA process. By ensuring that generic drugs remain safe, effective, and accessible, the ANDA framework continues to play a vital role in public health.
Keywords Abbreviated New Drug Application (ANDA), bioequivalence, patient safety, therapeutic efficacy, regulatory framework, generic drugs.
Field Medical / Pharmacy
Published In Volume 6, Issue 4, July-August 2024
Published On 2024-08-17
Cite This Patient Safety and Efficacy Considerations in Abbreviated New Drug Application (ANDA) Evaluation: Balancing Access and Regulation - Samyukta D, Senthil Kumar N, Senthil Kumar B - IJFMR Volume 6, Issue 4, July-August 2024. DOI 10.36948/ijfmr.2024.v06i04.26206
DOI https://doi.org/10.36948/ijfmr.2024.v06i04.26206
Short DOI https://doi.org/gt7m5m
View / Download PDF File

Share this



E-ISSN 2582-2160
CrossRef

CrossRef DOI is assigned to each research paper published in our journal.

IJFMR DOI prefix is
10.36948/ijfmr

Downloads
Research Paper Format Copyright Permission Form and Undertaking Form Cover Page Vol 6 Isu 6Cover Page Vol 6 Isu 5Cover Page Vol 6 Isu 4

All research papers published on this website are licensed under Creative Commons Attribution-ShareAlike 4.0 International License, and all rights belong to their respective authors/researchers.

CC-BY-SA Open Access

About IJFMR
Fees & Payment
Current Issue
Publication Archive 		Submit Research Paper
Track Submission Status
Publication Guidelines
Publication Ethics
Peer Review & Plagiarism 		Join as a Reviewer
Editors & Reviewers
Reviewer Referral Program
Get Reviewer Membership Certi. 		Website/Journal Policies
Usage Policy
Content Policies
Privacy Policy
Contact Us +91-9898-5948-55 editor@ijfmr.com