Perspectives on microsampling: DBS.
The concept of microsampling and particularly the dried blood spot methodology has been widely known to the scientific community for considerable time. Yet, there is no formal standard approach available to date for the pharmaceutical community to benefit from, in its regulatory interactions. This article discusses the various aspects of these issues and provides a framework within which a standard set of procedures can be adopted.
CT Viswanathan & Associates Inc., Rockville, MD 20855, USA. vishct@gmail.com
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Viswanathan
D000818:Animals; D001800:Blood Specimen Collection / Q000379:methods*; D059788:Dried Blood Spot Testing / Q000379:methods*; D055808:Drug Discovery; D017408:Guidelines as Topic; D006801:Humans; D010599:Pharmacokinetics; D014481:United States; D014486:United States Food and Drug Administration; D054928:Validation Studies as Topic