Clinical Trials Feature Articles

  1. Stability Testing: Mapping, Qualification, And Monitoring Temperature And Humidity 12/24/2008
    Stability testing and monitoring is a critical step in drug research, development and manufacturing. It impacts how pharmaceuticals are produced, packaged, labeled and sold. However, creating the exact environmental conditions in a stability test is a complex process, but necessary to comply with standards defined by regulatory bodies like ICH and the FDA as well as to ensure the safety and efficacy of pharmaceutical products. By Veriteq Instruments
  2. White Paper: Stability Testing — Mapping, Qualification, And Monitoring Temperature And Humidity 12/24/2008
    Stability testing and monitoring is a critical step in drug research, development and manufacturing. It impacts how pharmaceuticals are produced, packaged, labeled and sold. However, creating the exact environmental conditions in a stability test is a complex process, but necessary to comply with standards defined by regulatory bodies like ICH and the FDA as well as to ensure the safety and efficacy of pharmaceutical products. By Veriteq Instruments
  3. Automated Solutions For Monitoring Critical Environmental Factors 11/10/2008
    The environment in which pharmaceuticals reside is critical during all phases — research and development, manufacturing, compounding, and storage. Numerous regulatory agencies set forth criteria for ensuring that environmental factors do not adversely affect these products. Key aspects to maintaining compliance include documentation, continuous recording of data, full traceability, alarm notification, and corrective action taken and documented. By Gayle Wilton, Marketing Manager, Rees Scientific Corporation
  4. ISO 21501 — A Standard Methodology To Optical Particle Counter Calibration And What It Means To Cleanroom Owners 10/6/2008
    ISO 21501 is a new family of standards describing the instruments and calibration requirements for determining particle size distribution using light interaction methods. It represents the culmination of work by instrumentation manufacturers and industry users and comes at a critical time for the life science industry with the increasing trend for real-time air particle monitoring in cleanrooms using light scattering air particle counters. By Tony Harrison and Bob Latimer, Hach Ultra Analytics
  5. White Paper: Monitoring Trihalomethanes In Pharmaceutical Water Using A Direct Conductometric TOC Analyzer 9/2/2008
    Trihalomethanes (THMs) are potential by-products of the drinking water disinfection process and are formed when naturally occurring organic materials found in water react with chlorine, the most common drinking water disinfectant. The EPA enforces limits of these by-products because they "have been shown to cause cancer and reproductive defects in lab animals and suggested bladder cancer and reproductive defects in humans." By Terry Stange, Ph.D., Vice President Research and Development, Hach Ultra Analytics
  6. White Paper: PAT And TOC Analysis With An Onboard Automated Standards Introduction System (OASIS™) 9/1/2008
    This paper describes the use of an on-board automated standards introduction system (OASIS™) that is used to run verification standards and system suitability tests in order to ensure the reliability of the TOC results. The speed and efficiency gained by use of this automated system means that the analyzer is verified quickly, bringing a risk-based approach to ensuring product quality. By Steven Smith, Hach Ultra Analytics
  7. PAT And TOC Analysis With An Onboard Automated Standards Introduction System (OASIS™) 9/1/2008
    This paper describes the use of an on-board automated standards introduction system (OASIS™) that is used to run verification standards and system suitability tests in order to ensure the reliability of the TOC results. The speed and efficiency gained by use of this automated system means that the analyzer is verified quickly, bringing a risk-based approach to ensuring product quality. By Steven Smith, Hach Ultra Analytics
  8. Manual Vs. Automated Lab Monitoring 8/28/2008
    The laboratory houses critical equipment—refrigerators, freezers, incubators and more—that needs to be monitored and maintained. Contained within this equipment are precious commodities such as blood, platelets, tissue and reagents all requiring support and monitoring of their own. By Gayle Wilton, Marketing Manager, Rees Scientific Corporation
  9. White Paper: Manual Vs. Automated Lab Monitoring 8/28/2008
    The laboratory houses critical equipment—refrigerators, freezers, incubators and more—that needs to be monitored and maintained. Contained within this equipment are precious commodities such as blood, platelets, tissue and reagents all requiring support and monitoring of their own. By Gayle Wilton, Marketing Manager, Rees Scientific Corporation
  10. Recent Options For Phase I Formulation Development And Clinical Trial Material Supply 8/14/2008
    Pharmaceutical companies are challenged with choosing a dosage form that will reach clinical studies quickly and that can be made using a cost-effective process. To meet the demands of early-stage development, contract research organizations can evaluate various dosage-form options. By Balaji V. Kadri, Xcelience