Clinical Trials Feature Articles

11. White Paper: Safety First: The Impact Of New Regulations On Clinical Development
    8/25/2009

    A series of high-profile drug withdrawals in recent years has brought safety concerns to the fore, prompting more rigorous monitoring requirements from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). By ICON Clinical Research

12. Case Study: Hepatic Fat Accumulation In Hyperlipidemic Patients As Measured By Magnetic Resonance Spectroscopy And Magnetic Resonance Imaging
    3/10/2009
    When used in combination, magnetic resonance spectroscopy (MRS) and magnetic resonance imaging (MRI) can offer unique advantages in the study of hepatic fat in hyperlipidemic patients. MRI assesses differences in local environments to produce high contrast images, while MRS is capable of displaying minute differences in the magnetic properties of different chemical compounds to provide a unique biochemical signature. As a result, MRS can quantify important information on cellular activity and metabolism within the imaged region. By ACR Image Metrix
13. Hepatic Fat Accumulation In Hyperlipidemic Patients As Measured By Magnetic Resonance Spectroscopy And Magnetic Resonance Imaging
    3/10/2009
    When used in combination, magnetic resonance spectroscopy (MRS) and magnetic resonance imaging (MRI) can offer unique advantages in the study of hepatic fat in hyperlipidemic patients. MRI assesses differences in local environments to produce high contrast images, while MRS is capable of displaying minute differences in the magnetic properties of different chemical compounds to provide a unique biochemical signature. As a result, MRS can quantify important information on cellular activity and metabolism within the imaged region. By ACR Image Metrix
14. Case Study: Validation Strategy For A Sterility Testing Isolator Project
    2/24/2009
    This document provides an overview on how to properly validate sterility test isolator systems and then, via a case study, describes a strategy for streamlining the validation process when equivalent isolators and/or generators are installed in a sterility test suite. By James R. Rickloff, Partner/Scientific Director Advanced Barrier Concepts, Inc.
15. Case Study: Building Safety Into Isolator Controls Systems
    2/10/2009

    As isolators become more customized to meet the requirements of specific Pharmaceutical processes, the controls systems have been challenged to provide more safety and flexibility. By Walker Barrier Systems

16. ICON Insight: Imaging And Cardiology
    12/23/2008

    Imaging has an increasing role in the evaluation of cardiac safety where it is used together with adverse events, ECG, and laboratory tests for cardiac enzymes to assess for cardiac toxicity. This is most often found where animal studies suggest possible signal for safety concern, or where cardiac toxicity is a known class effect for toxicity. By Jonathan Goldman, M.D., FACC, Chief Medical Officer, ICON Medical Imaging

17. Malaria Vaccine Characterization With Multi-Angle Light Scattering
    12/22/2008
    The Wyatt SEC-MALS results clearly indicated the presence of three populations, monomer, dimer and tetramer, which was later verifi ed by boundary sedimentation equilibrium studies. By Wyatt Technology Corporation
18. Malaria Vaccine Characterization With Multi-Angle Light Scattering
    12/22/2008
    The Wyatt SEC-MALS results clearly indicated the presence of three populations, monomer, dimer and tetramer, which was later verifi ed by boundary sedimentation equilibrium studies. By Wyatt Technology Corporation
19. 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
20. ICON Insight: Pharmacodynamic Models In Phase I Clinical Trials — A Dynamic Approach
    10/1/2008

    The primary focus in Phase I clinical trials has traditionally been the assessment of safety, tolerability, and pharmacokinetics. However, the past decade has seen increasing interest in the application of biomarkers and surrogate endpoints in healthy volunteer studies, to provide information on the putative efficacy, dose response and time effects of investigational drugs. By John Connell, PhD, Senior Director, Scientific & Clinical Operations, ICON Development Solutions