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Icbiocro | clinical research, clinical trials, BE studies - Part 2

Glenmark gets approval to trial favipiravir for Covid-19 in India

Glenmark Pharmaceuticals has received approval from the Drug Controller General of India (DCGI) to evaluate antivirial drug favipiravir in clinical trials to treat patients with Covid-19. Favipiravir is a generic version of Fujifilm Toyama Chemical’s influenza drug Avigan, which holds approval in Japan for treating new influenza virus infections. Glenmark developed the drug’s API and formulations internally. Following the regulatory approval, the new trial will assess the product in Covid-19 patients with mild to moderate infection. Around 150 patients will be enrolled for the study. Participants will be given favipiravir plus standard supportive care or only standard supportive care. Treatment duration of the trial is a maximum of 14 days and the total study duration will be a maximum of 28 days from randomisation. Glenmark Pharmaceuticals Global R&D executive...

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5 Tips associated with effective Regulatory medical writing

The key objective of developing prime-quality regulatory writing is usually undervalued. Properly composed report help in the consequent production of quality document. Here are some useful tips that help to prepare an effective Regulatory medical writing. Understanding the objective:The foremost idea is to understand the key goal of the...

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Importance of BA & BE Studies

With the development of new drugs, pharmacokinetics has emerged as one of the most important parts. Bioavailability (BA) and Bioequivalence (BE) studies play a vital role during the phase development of both types of innovator and generic drugs. In this particular article, we will understand the importance of BA...

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Importance of Clinical Data Management

The success of every clinical trial relies on data accurately generated, gathered, and analyzed. Due to its high numbers involved, drug manufacturers, manufacturers for medical devices, biologics, as well as other life sciences organizations are turning to Importance of Clinical Data Management (CDM) alternatives to assure their quality of...

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