Bioavailability/Bioequivalence Studies Featured Articles

1. How Do I Get My Compound Into Phase I? 4/2/2014

   The primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials. By Dr. Scott E. Boley and Greg Ruppert

2. Repurposing And Rescuing Pharmaceutical Drugs 4/26/2013

   Repurposing marketed drugs or rescuing compounds that failed in clinical trials offers entrepreneurs the potential to replenish pipelines with reduced risk and time.

3. 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

4. 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.

5. Make Your CRO An Extension Of Your Internal Team 3/4/2013

   The healthcare contract research outsourcing market is expected to grow from $25.1 billion in 2011 to $65 billion by 2018. Eight industry experts discuss how to turn your CRO into a strategic partner.

6. Quality By Design, Should Pharma & Biotech Suppliers Be Ready? 1/31/2013

   Quality by design, oh my … is it salvation or mere vexation for manufacturing and other suppliers to pharma and biotech companies — or something else entirely? 

7. 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

8. Smart Sourcing At the Outset 10/31/2012

   When companies don’t have the in-house resources to characterize and refine truly novel compounds, they must rely on suppliers who do. Embrace the idea of early, painstaking characterization – using the most well-equipped and innovative suppliers as needed to put your product and company on sound strategic footing.

9. 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

10. 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