PK/PD Featured Articles
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Toxicometabolomics For Compound Attrition To Reduce Late Stage Failures Due To Safety
4/10/2013
Many ’omics’ technologies have now become the primary way of discovering new biomarkers, and validation of these biomarkers is a relatively new and evolving concept. By Michael V. Milburn, John A. Ryals, and Lining Guo
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Former Acorda Chief Medical Officer Discusses Benefits And Pitfalls Of Outsourcing
3/18/2013
Dr. Thomas C. Wessel, former chief medical officer for Acorda Therapeutics, recently shares his expertise acquired from working with the clinical development and operations, regulatory affairs, biostatistics, data management and drug safety functions.
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Considerations In Using Foreign Trial Data In U.S. NDA Submissions
8/3/2012
More and more drug companies are finding it financially advantageous to conduct clinical trials in foreign countries and to include data from these trials in NDA submissions. When offshore trials are properly conducted and the data is properly handled, this strategy can accelerate approval and lower the cost of drug development. By Ken Phelps, Camargo Pharmaceutical Services
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The Development And Validation Of Specific Ligand Binding Methods For The Determination Of Parathyroid Hormone (1-34) And (1-84) In Human Plasma For Pharmacokinetic Sample Analysis
9/2/2011
Parathyroid hormone (PTH) is an 84 amino acid polypeptide produced in the parathyroid gland and plays a major role in regulating serum calcium concentrations.