Dissolution testing continues to add value throughout the drug-development continuum. It serves as a tool for characterizing
an API; developing, selecting, and optimizing formulations; studying drug-release mechanisms; ensuring batch-to-batch consistency;
monitoring stability; and demonstrating bioequivalence between formulations. Dissolution testing can also help link the design
space and target product profile. With the increasing application of BCS and QbD approaches, the value and appropriateness
of dissolution testing for a given product will need to be assessed. Dissolution may not be needed or may be replaced by a
suitable related or surrogate test to control the critical quality attributes of the product. Increased scientific understanding
and experiences should lead to harmonized principles recognized by both industry and regulatory agencies with regard to the
continued use and value of dissolution testing.
The authors wish to acknowledge the thoughts, ideas, and comments from the In Vitro Release and Dissolution Testing Focus Group. They also wish to thank Mary Ann Quarry, PhD, for her editorial input.
Cheng Tong is a senior principal scientist at Pfizer Inc., Ruben Lozano is a principal scientist at Bristol-Myers Squibb, Yun Mao is a research fellow at Merck Co., Tahseen Mirza is a director at Novartis, Raimar Löbenberg is an associate professor at the University of Alberta in Canada, Beverly Nickerson is an associate research fellow at Pfizer Inc., Vivian Gray is president of V.A. Gray Consulting, and Qingxi Wang* is a director at at Merck Co., tel. 215.652.1302, fax 215.652.2835, firstname.lastname@example.org
. All authors are part of the American Association of Pharmaceutical Scientists (AAPS) In Vitro Release and Dissolution Focus Group.
*To whom all correspondence should be addressed.
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