Articles

51. Product & Process Transfer Of Low Solubility Compound With 6 Year OTIF>95% 9/28/2011

    Alkermes, through the merger with Elan Drug Technologies, to form Alkermes plc, has been developing and manufacturing commercial scale solid oral dosage products for over 40 years. This case study demonstrates the successful transfer of a low solubility compound into one of our manufacturing sites and achieving as a result, an OTIF (On-Time-In-Full) consistently over 95%.

52. Clinical Trials In Russia 8/26/2011
    The Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (Roszdravnadzor) and the Ministry of Health and Social Development of the Russian Federation (MoH) approved 492 new clinical trials of all types including local and bioequivalence studies during 2010, demonstrating a 15% decrease from the last year figure.
53. White Paper: Foreign Clinical Trial Data 8/5/2011
    Given the high cost of moving a promising drug candidate through years of clinical trials, it’s no wonder that more and more drug manufacturers have begun conducting at least some of their clinical trials in foreign countries. With lower costs and shorter recruiting times, the use of foreign sites is appealing to all drug developers, but especially to those involved in generic and “fast-track” approval programs.
54. White Paper: Clinical Trial Material Production And Testing: What Your CMO Is Not Telling You 6/7/2011
    Manufacturing clinical trial material (CTM), and the costs for the associated fill/finish and release work, most likely are not the costliest portions of the pharmaceutical process chain. By Alexander Mello, Director, Project Management
55. White Paper: Pharmaceutical Sterility Testing — Essential Things You Must Know 6/7/2011

    Sterility testing of pharmaceutical articles is required during the sterilization validation process as well as for routine release testing. An understanding of sterility testing is beneficial in terms of designing a validation process. By Steven G. Richter, Ph.D

56. Bio Data Points 5/19/2011
    Nearly all biopharmaceutical developers use outsourcing services of some kind, whether for manufacture of clinical or commercial supplies, assays, process development, or many other activities. By Eric Langer, president and managing partner, BioPlan Associates, Inc.
57. White Paper: Bio Data Points 5/19/2011

    Nearly all biopharmaceutical developers use outsourcing services of some kind, whether for manufacture of clinical or commercial supplies, assays, process development, or many other activities. By Eric Langer, president and managing partner, BioPlan Associates, Inc.

58. Proven Treatment Value Commercial Solutions 5/13/2011
    For every biopharma company, it’s the ultimate goal—a drug that delivers demonstrable patient benefits, that physicians recommend and prescribe, and whose cost/ benefit profiles payers endorse.
59. TQT Solutions 5/11/2011
    The increasingly complex regulatory environment has focused an intense spotlight on cardiac safety. You now have to produce more evidence with greater accuracy for the full spectrum of therapeutic areas.
60. Case Study: Flu Vaccine Trial Accelerated Despite Late-In-Season Start 5/11/2011
    Streamlined processes for study startup, coupled with experience in vaccine trials and solid relationships with study sites and investigators, helped this Quintiles team meet the challenge of starting an influenza vaccine trial late in the influenza season.