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INTERNATIONAL JOURNAL OF CREATIVE RESEARCH THOUGHTS - IJCRT (IJCRT.ORG)
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ISSN Approved Journal No: 2320-2882 | Impact factor: 7.97 | ESTD Year: 2013
Call For Paper - Volume 14 | Issue 3 | Month- March 2026
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Published Paper Details:
Paper Title
COMPREHENSIVE STUDY OF REGULATORY REQUIREMENT FOR PRODUCT DEVELOPMENT AND QUALITY CONSIDERATION GUIDELINES OF TDS IN US AND EU.
Authors
Pooja Bhausaheb Kolse, Onkar Appasaheb Kharat, Mayur Mansaram Patil, Rushikesh Madhukar Sonawane, Snehal Santosh Pendbhaje
Keywords
Medicinal divices, Medicines, GMP, EUGMP
Abstract
This thesis covers initial variant submissions for transdermal patches intended for systemic distribution as well as new marketing authorization applications (including generic or abbreviated applications).
There is guidance on the standards of quality for transdermal patch development, manufacture, excipient characterization, drug product control, packaging, and stability. In vitro performance testing is examined in particular with regard to drug release, adhesion, and skin permeability, as well as its relationship to clinical and in vivo performance.
Along with the Guideline on the Pharmacokinetic and Clinical Evaluation of Modified- Release Dosage Forms, it should be read.
Transdermal patches are made to distribute the active substance(s) via the skin in a regulated manner, primarily by diffusion, with a certain pace and amount of systemic absorption.
IJCRT's Publication Details
Unique Identification Number - IJCRT2411819
Paper ID - 271753
Page Number(s) - h356-h390
Pubished in - Volume 12 | Issue 11 | November 2024
DOI (Digital Object Identifier) -
Publisher Name - IJCRT | www.ijcrt.org | ISSN : 2320-2882
E-ISSN Number - 2320-2882
Cite this article
Pooja Bhausaheb Kolse, Onkar Appasaheb Kharat, Mayur Mansaram Patil, Rushikesh Madhukar Sonawane, Snehal Santosh Pendbhaje, "COMPREHENSIVE STUDY OF REGULATORY REQUIREMENT FOR PRODUCT DEVELOPMENT AND QUALITY CONSIDERATION GUIDELINES OF TDS IN US AND EU.", International Journal of Creative Research Thoughts (IJCRT), ISSN:2320-2882, Volume.12, Issue 11, pp.h356-h390, November 2024, Available at :http://www.ijcrt.org/papers/IJCRT2411819.pdf
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Call For Paper March 2026
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March 2026
Volume 14 | Issue 3
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31-Mar-2026
Submit Manuscript Online Impact Factor: 7.97 Review Results : Within 02-03 Days Paper Publication : Within 02-03 Days
March 2026
Volume 14 | Issue 3
Last Date :
31-Mar-2026
Submit Manuscript Online Impact Factor: 7.97 Review Results : Within 02-03 Days Paper Publication : Within 02-03 Days
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ISSN: 2320-2882 Impact Factor: 7.97 and ISSN APPROVED Journal Starting Year (ESTD) : 2013
ISSN and 7.97 Impact Factor Details
ISSN: 2320-2882 Impact Factor: 7.97 and ISSN APPROVED Journal Starting Year (ESTD) : 2013
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