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  • Posted in: AAPS Community

    Dear All, we are planning to establish a Master/Working Cell bank system to support a Bioassay (potency test) for release (QC assay) according to USP <1032> guideline. We have a cell line growing in "classical" conditions, I mean with serum, with Pen/Strep, ...

  • Posted in: AAPS Community

    I would like to propose to include word Quality in the first statement. I must have missed GopiV's comment re Clinical practices. I also did not fully comprehend legal aspects of pharmaceutical development and intellectual property? Regulatory ...

  • Posted in: AAPS Community

    Hi  I agree with Lynn - regulatory sciences must be multidisciplinary if an organization is to be successful.  And a modicum of common sense is always a plus!  Best - Janet ------------------------------ Janet Rea MSPH, RAC Sr. VP Regulatory, Quality ...

  • Posted in: AAPS Community

    Hi everyone – It seems there has been a lot of interest in a Regulatory Community! Did you know that you can start the discussion now in the AAPS Community by tagging relevant threads with #Regulatory ? Just by typing that out, this tag has now been ...

  • Posted in: AAPS Community

    ​ There has been a noted increase in the number of major pharmaceutical companies with oligonucleotide based drugs in their pipelines.  However, there is no currently regulatory guidance that directly address oligonucleotides as they are not truly small ...

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  • Posted in: AAPS Community

    The updated community name -- Regulatory "Scientists", and the new mission statement is more inclusive and interdisciplinary. They reflect the nature of Regulatory Sciences and Regulatory Affairs. I hope this community will serve more regulatory colleagues ...

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