How Microdosing Can Play a Role in Early Phase Clinical Trials

Microdosing in Early Phase
By Steve Unger, Laboratory Director, Early Phase Services, Worldwide Clinical Trials,

  Why would anyone need a regulated bioanalytical assay that measures plasma concentrations far below the potency of a drug? This question came up as our Early Phase Team was preparing for the Workshop on Recent Issues in Bioanalysis (WRIB), which will be held April 9-13 in Philadelphia. If you plan to be there or have questions about early phase trial issues, please fill out a general inquiry form and specify to be in contact with Michele Malone, Senior Director, Early Phase Services/Bioanalytical Sciences, Worldwide Clinical Trials.

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Are Electronic Data Capture and Early Phase Clinical Research Still an Unlikely Pair?

Electronic Data Capture (EDC) in clinical research
By Dr. George Atiee, Vice President and Medical Director at Worldwide Clinical Trials Early Phase Services Unit,

  At a time when technology is well and truly embedded within people’s everyday lives, the adoption of modern technology within clinical research has been an obvious step forward for the industry. Fifteen years ago, Electronic Data Capture (EDC) in clinical research was still a relatively rare entity. However, fast forward to today’s clinical trials and electronic data capture solutions have a proven track record of supporting studies of all sizes and complexities.

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Pharmacovigilance and Drug Safety: Defining and Maintaining Drug Dosing Safety Margins in Clinical Trials

Clinical proof-of-concept, No-Adverse-Effect Level and Dose-Limiting Toxicity
By Steve Unger, Laboratory Director, Worldwide Clinical Trials Early Phase Services,

Drug candidate selection includes perspectives from numerous disciplines (drug discovery, drug safety, drug metabolism and pharmacokinetics (DMPK), pharmaceutics, clinical pharmacology and biostatistics).  Many organizations use the fail fast model by integrating development functions into discovery to minimize failures in preclinical Good Laboratory Practice (GLP) studies.  More forward testing allows organizations to select better compounds and to build better, long-term development plans.

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