Paradigm shift in clinical trial regulations in India
| Autor: | Sandeep Lahiry, Rajasree Sinha, Shouvik Choudhury, Ayan Mukherjee, Suparna Chatterjee |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: | |
| Zdroj: | Indian Journal of Rheumatology, Vol 13, Iss 1, Pp 51-55 (2018) |
| Druh dokumentu: | article |
| ISSN: | 0973-3698 0973-3701 |
| DOI: | 10.4103/injr.injr_110_17 |
| Popis: | India has the potential to contribute meaningfully to global clinical drug development. A critical enabler to achieve this potential is a balanced, predictable, and scientifically robust regulation involving clinical studies. In the past few years, the country's regulatory milieu has witnessed a positive transformation to favour ethical conduct of clinical trials, while appropriately supporting patient safety. Numerous amendments to existing policies governing the conduct of clinical studies are predicted to bring a paradigm shift in the overall regulatory scenario. In such view, it is important for us as academicians, to be abreast of such changes. We, therefore, discuss major regulatory highlights involving clinical research in India. |
| Databáze: | Directory of Open Access Journals |
| Externí odkaz: |
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