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“Pacific Pharma Group offers efficient product development through thoughtful design.”
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Asian Population Studies
Global development strategies increasingly include China, Korea, Taiwan, and other East Asian countries. Although the regulatory pathway is not as well defined and traveled as for Japan, as a member of ICH, the issues are generally similar.
Additionally, studies with Asian populations are increasingly important for FDA approval, because:
* The US Asian population is increasing;
* Asians have traditionally been under represented in US clinical trials; and
* Asian populations represent considerable diversity, including heterogeneity of CYP and other pharmacologically relevant enzymes such that they may require adjustments in the recommended dose of substrate medications.
Whether your strategy requires Asian populations with the intent of Asian registration, US labeling, or both, Pacific Pharma Group, LLC has the relevant experience to provide guidance.
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