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Dear PharmPK members
I would appreciate getting your thoughts on the types of studies (in vitro and/or in vivo) needed to assess the drug-drug interaction potential of novel therapeutic proteins? Are the standard in vitro assays relevant?
Many thanks
Ofer
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Ofer,
General answer to your general question is no, standard in vitro assays are mostly not relevant as interactions are usually not direct.
Here are several references and links that you may find useful:
Zhou H., Davis H. Risk-based strategy for the assessment of pharmacokinetic drug-drug interactions for therapeutic monoclonal antibodies. Drug Discovery Today, Volume 14, Issues 17-18, September 2009, Pages 891-898.
http://www.njacs.org/docs/NJDMDG-2009-Fall-slides-Theil-DDI-Protein-Therapeutics.pdf
http://www.isciencex.com/DDI-2009%20Program%2002-09-09.htm
K. Seitz, H. Zhou.Pharmacokinetic Drug-Drug Interaction Potentials for Therapeutic Monoclonal Antibodies: Reality Check. J Clin Pharmacol 2007;47:1104-1118
I.Mahmood, M. Green. Drug Interaction Studies of Therapeutic Proteins or Monoclonal Antibodies. J. Clin. Pharmacol. 2007; 47; 1540-1554.
Regards,
Katya
--
Ekaterina Gibiansky, Ph.D.
CEO&CSO, QuantPharm LLC
Web: www.quantpharm.com
Email: EGibiansky at quantpharm.com
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