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With the advent of new era of pharmaceutical dosage forms, transdermal drug delivery system (TDDS) established itself
as an integral part of novel drug delivery systems. Transdermal patches are polymeric formulations which when applied
to skin deliver the drug at a predetermined rate across dermis to achieve systemic effects and from past 30 years there were
several advancements in its development process and latest technologies are available in the market. The demand for globally
acceptable transdermal products heightens the imperative for harmonization of regulatory requirements to lend efficiency and
cost effectiveness to the process of product development, manufacturing and expediency to global access, and where generic
companies are playing a crucial role to make them affordable. Hence review process by the regulatory authorities acts a vital role
for approval of generics and the process is also being very stringent in various countries such as United States, Europe, Canada,
Australia, and Japan includes standard skin irritation, sensitization and adhesion studies with the patch itself in animals/humans.
The production of transdermal drug delivery system medications has increased, because these sorts of systems have proved more
effective in many situations at directly sending drugs into the body.
Ch. Teja is currently pursuing her 2nd year M. Pharmacy in Pharmaceutical Regulatory Affairs from JSS University, Mysore. She has done her
graduation from the same college i.e. JSS College of Pharmacy, Mysore, Karnataka. She published 2 articles in reputed journals titled ?Comparative
Study of In- Process and Finished Products Quality Control Tests of Indian Pharmacopoeia, British Pharmacopoeia & United States Pharmacopoeia
for Capsules and Liquid Orals? and ?New Era in US Prescription Drug Labeling? Which was also published as a poster 63rd IPC. And also attended
Indo-American Pharmaceutical Regulatory Symposium- 2011 and presented a poster on ?Indian Regulations on Cosmetics?.
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