PK/PD 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. 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.

  8. 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

  9. 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.

  10. Gaining Greater Predictability, Control And Quality In Bioprocessing With Metabolic Biomarkers

    Biologics are an integral part of the landscape of current therapies as pipelines continue to fill with them. Due to their importance and this ever expanding pipeline, the demands continue to escalate due to cost pressure, competition, regulatory requirements, disposable systems, and biosimilars. To date, these demands arguably have primarily been met with empirical understanding. However, there is a critical need for new approaches, tools, and technologies to deliver deeper understanding beyond the empirical realm. By Dr. Kirk Beebe, Director of Application Science, Metabolon, Inc.