Drug Development In The United States

The modern uses of clinical pharmacology data in the United States may be thought of as having several phases, beginning with early efforts in the 1970s, which related to the increased availability of sensitive and specific analytical methods around that time. This was followed by application of these capabilities to various areas such as the study of specific subpopulations. Further implementation has emphasized the link of pharmacokinetic data to clinical safety and efficacy data. Most recent emphasis has included better understanding of drug interactions and optimal dose adjustment for various sub-populations. Communication of information and recommended approaches has been facilitated by the preparation of FDA Guidances as well as ICH Guidelines.

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