Research & Reviews: A Journal of Drug Formulation, Development and Production
Volume 3, Issue 3 (2016)
Published
Table of contents
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Electronic Common Technical Document (eCTD): A Review of History, Benefits of Implementing, Challenges, Modules and Risks Involved in eCTD Publishing
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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A Brief Note on Different Concept of Biowaiver
Abstract: The aim of the present work was to understand the concept of to waive a complete and systemic bioequivalence (BE) study. Biowaiver or request for a biowaiver is a fast track approach to boost the drug development process. Over the past three-four years, the biowaiver market has shown greater number of biowaiver submissions and the wider use of in-vitro permeability study. Biowaiver is a beneficial approach for getting approval of …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 3, Issue 3, 2016 · pp. 22–30 Read article
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In Vitro–In Vivo Correlation (IVIVC): A Strategic Tool in Drug Product Development
Abstract: In a recent era many concepts are dealing as an emerging tool for the drug delivery application like Biopharmaceutical Classification System (BCS), In vitro and In vivo study, and Bioavailability/Bioequivalence (BA/BE) study etc. To determine Therapeutic efficiency in vitro is not enough so the concept of In vitro-In vivo correlation (IVIVC) is playing as an convincing correlation with this for concept of pharmaceutical dosage forms have been a main focus …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 3, Issue 3, 2016 · pp. 31–54 Read article
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Hepatic Disorders: Ayurvedic Perspective
Abstract: Kamla is a very common disease in our country. It is difficult to diagnose. If properly diagnosed, the Sadhya: asadhyat (prognosis or curability and incurability) can be forecasted easily. The patient also can be informed what treatment is to be given. Varieties: Ayurvedic classics give two types of Kamla, viz Kosthashrit and Shakhashrit (Caraka Sutra) while in chikitsa 16 maharishi Caraka has classified the same in two different names: (1) …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 3, Issue 3, 2016 · pp. 55–59 Read article