3 publications
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Published Subscription
Drug Approval Procedure in India (CDSCO)By Praveen Agarwal, Deepak Bhandary, Abdul Rasheed
Abstract: A regulatory process, by which a person/organization/sponsor/innovator gets sanction to launch a drug in the market, is kenned as drug approbation process. In general, a drug approbation process comprises of sundry stages: application to conduct clinical tribulations (CT), conducting clinical tribulations, application to marketing sanction (MA) of drug and post-marketing studies (PMS). Every country has its own regulatory ascendancy, which is responsible to enforce the rules and regulations and issue …
Published in Research & Reviews: A Journal of Drug Design & Discovery · Vol. 2, Issue 2, 2015 · pp. 20–26 Read article →
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Published Subscription
Electronic Common Technical Document (eCTD): A Review of History, Benefits of Implementing, Challenges, Modules and Risks Involved in eCTD PublishingBy Praveen Agarwal, Anil Dewangan, Pavani Duggi
Abstract: Electronic Common Technical Document (eCTD) is a topic of increasing interest in the pharmaceutical environment. eCTD is an interface for the pharmaceutical industry to agency transfer of regulatory information. Since June 2003, applicants have had the option of submitting an eCTD in parallel with the paper submission (Common Technical Document), following sign-off by the International Conference on Harmonization Steering Committee of the eCTD Specification document at Step 4. It is …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 3, Issue 3, 2016 · pp. 1–16 Read article →
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Published Subscription
Drug Product Registration and Regulatory Requirements in Australia (TGA)By Praveen Agarwal, Mudit Dixit, R Narayana Charyulu, Deepak Bhandary
Abstract: The present study aims to understand the drug product regulatory requirements and drug product registration process in Australia. Therapeutic Goods Administration (TGA) is the regulatory authority for Australia and is responsible for regulating medicines and medical devices. However, as known, each country has its own regulatory agency to enforce the rules and regulate the guidelines to market a drug substance and drug product. To get authorization of marketing of drug …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 2, Issue 1, 2015 · pp. 7–15 Read article →