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Retention Samples in Clinical Trials

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  • Ruth Lopez
    23/08/2019 18:07
    Do retention samples from clinical studies need to fulfil any special consideration in terms of storage than the commercial drugs? Annex 13 is so general about it. I have consulted some other guidelines (PDA guidelines) but I could not find any information that only applies for clinical trials. Thank you in advance for your support.
  • Anon
    23/08/2019 18:56
    Definately send this question to GMP Committee, they know about these sort of requirements
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