Bioavailability/Bioequivalence Studies Featured Articles

1. 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

2. 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.

3. FDA's December 2012 Guidance On IND And BA/BE Reporting - Part III 1/22/2013

   Continuing with the review of the key points in FDA’s guidance. This is the final part. By Bart Cobert

4. Comment On Biopharmaceutical Classification System And Formulation Development 10/26/2012

   This is the first installment in a series of articles that will provide an overview of an area of potential interest to the readers of Pharmaceutical Online and Outsourced Pharma. By Mark Mitchnick, MD, and Robert W. Lee, PhD

5. 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

6. Successful Bioanalysis Outsourcing In Support Of Drug Development Program: Key To Risk Mitigation Planning For Mid-Study Method Transfer 9/15/2011
   We have developed processes to enable consistent method performance during method transfer. This has ensured timely method transfer validation and study sample analysis in support of new drug development and product commercialization.
7. 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.