Articles

1. The Environmental Impact of Clinical Trials 8/8/2013

   For many years it has been almost universally accepted that there are various sources that may impact or cause disease among which biological, social, and environmental differences have all been investigated. Many clinical trials have been conducted to assess the impact of the environment on outcomes e.g., the effect of the environment on the outcome of studies assessing the efficacy of drugs for patients with dry-eye syndrome, the impact of diet on obesity and cardiovascular disease, and the impact of the environment on autoimmune diseases have all been studied, as have many other interactions.

2. Outsourcing Insights: Focusing On Innovation 4/12/2012

   In 2011, innovation was a major topic among the various players in the drug development industry. By Kate Hammeke, research manager, Nice Insight

3. Online Community Programs - Changing The Game 4/4/2012
   Why are online community programs being used to connect physicians and other healthcare professionals (HCP)?
4. Insights On Solid-Dose Manufacturing Roundtable 11/30/2011

   Highlights of this roundtable discussion with Regan include: solid-dose manufacturing evolution during the past 10 years, what the future holds for solid-dose manufacturing, common misconceptions with solid-dose manufacturing, and advice for those looking to purchase solid-dose manufacturing equipment. By Life Science Leader magazine

5. How Can I Avoid Mycoplasma Contamination And Other Serious Cell Culture Problems? 5/26/2010

   Cell culture research and engineering have greatly impacted human health, ranging from vaccine manufacturing to stem cell therapies, cell-based assays and cancer immunotherapeutic products. Critical to the success of these applications is the quality of the cultures used. The following article offers suggestions on management and protection of your cultures. By Bionique

6. 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