Approaches for Establishing Clinically Relevant Dissolution Specifications for Immediate Release Solid Oral Dosage Forms

@article{Hermans2017ApproachesFE,
  title={Approaches for Establishing Clinically Relevant Dissolution Specifications for Immediate Release Solid Oral Dosage Forms},
  author={Andre Hermans and Andreas M. Abend and Filippos Kesisoglou and Talia R Flanagan and Michael J. Cohen and Dorys Argelia Diaz and Yun Mao and Limin Zhang and Gregory K. Webster and Yiqing Lin and David Hahn and Carrie A. Coutant and H. Grady},
  journal={The AAPS Journal},
  year={2017},
  volume={19},
  pages={1537-1549}
}
This manuscript represents the perspective of the Dissolution Analytical Working Group of the IQ Consortium. The intent of this manuscript is to highlight the challenges of, and to provide a recommendation on, the development of clinically relevant dissolution specifications (CRS) for immediate release (IR) solid oral dosage forms. A roadmap toward the… CONTINUE READING