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India posts draft guidance on stability data for clinical trials

By Nick Taylor , 02-Jan-2012
Last updated the 02-Jan-2012 at 13:35 GMT

India has released draft guidance on stability data needed to support approval of Phase I to III clinical trials.

Like its US counterpart India’s Central Drugs Standard Control Organization (CDSCO) proposes unique stability data requirements for each phase of clinical development. Outlining these demands in draft guidance is intended to help biopharm companies support their applications with suitable data.

This guidance will ensure that sufficient data is submitted to CDSCO to assess the safety as well [as] the quality of the proposed clinical trials from chemical and pharmaceutical information perspective”, the regulator wrote. The guidance does not apply to biologics and vaccines.

For Phase I trials CDSCO, like the US Food and Drug Administration (FDA) , has minimal requirements. However, the approach is different, with CDSCO asking applicants to “submit whatever stability study data [is] available” and the FDA calling for samples to be tested for the duration of the Phase I trial.

As a compound advances through drug development CDSCO’s stability data requirements increase. In Phase II a minimum of one month accelerated and real-time stability study data is needed. CDSCO also asks for quarterly updates on stability and to be told of significant changes within 10 days.

The FDA guidance differs by making no mention of specific Phase II requirements, such as the one month of stability data. Also, the FDA asks firms to “consider the development of stability-indicating analytical procedures that will detect significant changes in the quality of the drug product”.

CDSCO Phase III needs are identical to its Phase II draft. In contrast, the FDA adds data requirements in Phase III, asking for one-time stress tests of certain products and development of a protocol for use in formal stability studies. This ensures data for the NDA (new drug application) is generated.

Comments can be sent to CDSCO until January 20.

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