Articles

  1. White Paper: Outsourcing Insights 5/19/2011
    If you have been in the pharmaceutical industry for an extended period of time, you’ve likely noticed how CROs have evolved from offering basic support to providing a wide range of clinical, central laboratory, and analytical services to meet market demands. By Victor Coker, director of business intelligence, Nice Insight
  2. Outsourcing Insights 5/19/2011

    If you have been in the pharmaceutical industry for an extended period of time, you’ve likely noticed how CROs have evolved from offering basic support to providing a wide range of clinical, central laboratory, and analytical services to meet market demands. By Victor Coker, director of business intelligence, Nice Insight

  3. Brochure: Custom Synthesis 12/6/2010

    PharmaZell draws upon a long history of successful custom synthesis projects, performed on a proprietary basis for pharmaceutical companies worldwide.

  4. Brochure: Drug Development 8/10/2010

    PharmaZell is your partner for custom synthesis and cGMP manufacturing of small molecule APIs and intermediates.

  5. Brochure: Contract Manufacturing 8/6/2010

    Drug Substance and Advanced Intermediate development and manufacture to support clinical through commercial requirements.

  6. Comprehensive Preclinical Development Program 4/9/2010
    Aptuit was asked to conduct an extended package of preclinical studies within a short time frame. As the critical studies are dependent on the results of earlier work in the package (for example, initiation of the 28 day toxicology studies are dependent on the completion of bioanalytical method development, dose range finding, etc.) not only scheduling, but adherence to the schedule was the major risk to achievement of the overall aim, and on time filing to the regulator. By Aptuit, Inc.
  7. Product Development Of An Inhaled Protein 4/9/2010
    A small biotechnology company in the United States turned to Aptuit to support the development of their inhaled respiratory product. They had added confidence that their limited in-house capability would benefit from Aptuit’s substantial experience and capabilities in respiratory science projects, fulfilling their need for first-in-class capabilities in manufacturing, clinical packaging and logistics, bio-analytics and respiratory analytics. By Aptuit, Inc.
  8. Poster: CMC For 505(b)(2) Applications 4/7/2010
    The Chemistry, Manufacturing, and Control (CMC) Section (Modules 2 & 3 of the Common Technical Document [CTD]) of any application to the FDA will be the cornerstone for demonstrating the quality of any drug product. A clear document that complies with the ICH Harmonized Tripartite Guideline per the ICH Steering Committee Meeting (9 Nov 2000) is instrumental to that process. By Lynn Gold, PhD, Ken Phelps, Kathryn Wekselman, PhD, RN, and Karen Seta-Aust, PhD, Camargo Pharmaceutical Services, LLC
  9. CMC For 505(b)(2) Applications 4/7/2010
    The Chemistry, Manufacturing, and Control (CMC) Section (Modules 2 & 3 of the Common Technical Document [CTD]) of any application to the FDA will be the cornerstone for demonstrating the quality of any drug product. A clear document that complies with the ICH Harmonized Tripartite Guideline per the ICH Steering Committee Meeting (9 Nov 2000) is instrumental to that process. By Lynn Gold, PhD, Ken Phelps, Kathryn Wekselman, PhD, RN, and Karen Seta-Aust, PhD, Camargo Pharmaceutical Services, LLC
  10. Q&A: Understanding The 505(b)(2) Approval Pathway 5/28/2009

    By the time he founded Camargo Pharmaceutical Services in 2003, Ken Phelps had already amassed more than 30 years of experience in the health science and services industry. With a broad background in drug development, specifically the 505(b)(2) regulatory approval pathway, Phelps has aided in the successful FDA approval of numerous compounds. Today, his company provides a full spectrum of drug development capabilities, from pre-clinical feasibility assessments to clinical program development to regulatory review and submission.

    In this Q&A, Phelps discusses 505(b)(2) — how it differs from 505(b)(1), its myriad of benefits, its continuing evolution, and its current and future impact on drug development.