27. June 2017

The International Conference on Harmonization (ICH) M9: Biopharmaceutics Classification System-based Biowaivers,1,2 was adopted in mid-June 2016. A biowaiver allows for in vitro testing to be used in lieu of in vivo bioavailability and/or bioequivalence studies to facilitate product approval, where solubility and permeability are not expected to impede bioavailability. ICH M9 will therefore minimize unnecessary in vivo studies in man and allow greater public access to vital medicines. However, t

31. March 2016

Presentation - James E. Polli University of Maryland Background Prior human in vivo studies Recent series of in vivo human studies of 14 common excipients Potential transporter (or enzyme or nuclear receptor) x excipient interaction concern Conclusions

21. February 2016

The aim of this study focus on the extended release formulation on two aspects: the quantification and mechanistic research on pharmaceutical coating curing with a specific focus on how the moisture affect the curing; and in vivo and in vitro release of matrix ER tablets with implications on regulatory biowaiver using marketed products as practical examples. In all cases, it was found that the relative humidity of the environments were more important to reach higher extent of coalescence for EC...

22. August 2015

Purpose Currently, the FDA allows biowaivers for Class I (high solubility and high permeability) and Class III (high solubility and low permeability) compounds of the Biopharmaceutics Classification System (BCS). Scientific evidence should be provided to support biowaivers for BCS Class I and Class III (high solubility and low permeability) compounds. Methods Data on the effects of excipients on drug permeability are needed to demonstrate that commonly used excipients do not affect the...

26. June 2015

08. February 2015

Article first published online: 6 FEB 2015 DOI: 10.1002/jps.24350 http://onlinelibrary.wiley.com/doi/10.1002/jps.24350/full