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THE PHARMA REVIEW (SEPTEMBER - OCTOBER 2016)

Registration Requirements of Topical Dermatological Products - A Regulatory Perspective

Balamuralidhara V.*, T.M. Pramod Kumar & Parasiya Sachinkumar Ravilal

Introduction: The study revolves around the specific regulatory requirements that govern the approval prospects of the Topical Dermatological products. Since the regulatory outcome decided the fate of these systems a special emphasis was made to cover the regulatory aspects of dermatological product and the study mandates the Quality by Design (QbD), and Critical Quality Attribute (CQA) approaches for designing, manufacturing and analyzing through timely measurements of raw and in-process materials with the goal of ensuring final product quality. Bioequivalence assessment of topical products has been studied using several different techniques. i.e., Human Skin Blanching Assay (HSBA), Tape Stripping (TS), Dermal Micro dialysis (DMD) and other In Vivo assessment techniques. 

 

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