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本帖最后由 beiwei5du 于 2018-2-27 22:24 编辑
https://www.gov.uk/government/publications/out-of-specification-investigations#full-history
Guidance Out-of-specification investigations
This Medicines and Healthcare products Regulatory Agency guidance for those carrying out of specification investigations covers: - Laboratory analysis
- Results
- Phase Ia investigations
- Phase Ib investigations
- Phase II investigations
- Phase III investigations
- Batch disposition
Published 28 August 2013
Last updated 26 February 2018
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