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  • Posted in: AAPS Community

    I'm the organizer for the upcoming Transporters workshop https://www.aaps.org/education-and-research/workshops/transporters18 . We're seeking feedback on what attendees want to learn more about (this will help us craft our sessions accordingly). What ...

    5 people recommend this.
  • Posted in: AAPS Community

    The innovator product claims its abuse deterrence based on their own in vitro and in vivo study results. Needless to say, all NDA applicants like to claim that for their own product, whether the FDA approves that claim is a whole different issue. To put ...

  • Posted in: AAPS Community

    Dear Kevin, please find some examples here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4809625/ PubMed Central (PMC) Good Practices in Model‐Informed Drug Discovery and Development: Practice, ...

  • Posted in: AAPS Community

    Dear Dr.Tzehaw Chen, The opinions about excipient compatibility for your 'moisture sensitive' formulation appears to be logical.But here we have to remember /cautioned about while doing compatibility studies with additional moisture (as advised by ...

  • Posted in: AAPS Community

    Hi, I would like to know about Abuse-Deterrent Opioid Formulations related analytical studies. The current guidance revised by FDA in November 2017 limits if the % opioid release > 50% for brand formulation. How the brand formulation can claim as "abuse-deterrent" ...

  • Posted in: AAPS Community

    Hi, In addition, i suggest open and close (dry or wet) condition for at least 1 month exposed to RT/ACC condition. Then analyse assay by HPLC or UPLC. ------------------------------ Murali Javvaji Sr. Research scientist Teva pharmaceuticals Miami ...


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