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  • Posted in: AAPS Community

    Hi Boris, The only official guideline I know of is the ICH Harmonised Tripartite Guideline issued in 1994 and finalized in 2005. It is the Validation of analytical Procedures: Text and Methodology Q2(R1). Let me know if you would like me to email you ...

  • Posted in: AAPS Community

    Hello Kishor Bupathi, I very highly recommend that you contact the regulatory experts at Camargo Pharmaceutical Services, they have several industry leading experts in the Biosimilar field: Website: https://camargopharma.com Phone: (513) 561-3329 or ...

  • Posted in: AAPS Community

    To all AAPS members: The PharmSci 360 convention scientific planning committee wants to know what you think are the hottest topics right now in your area! Would you please do us a favor and provide your opinion via this survey ? If you have any questions, ...

  • Posted in: AAPS Community

    ​Hi Dominic this is great information and thank you for sharing. when qualifying ELISPOT assays, which guideline document do you apply? in general, do you view TNTC as an acceptable response? alternatively would you suggest to dial it down so an actual ...

  • Posted in: AAPS Community

    John, Glad the CIC site was helpful. We used PBMCs with PHA. I believe the acceptance criteria was >250+ spots and was frequently TNTC. We used it as a positive surrogate control tor all studies. The second control we frequently used was a peptide cocktail. ...

  • Posted in: AAPS Community

    Dear All , Do you know anybody who has wealth of knowledge in filing and getting approval for Biosimilar? Looking for a consultant who can help us out. Thank you! Kishor bupathi 9084560083 Sent from my iPhone


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