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Fw: Superior clinical research - another example

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  • SinDee
    ... From: - V I N - Date: Wed, 31 Aug 2005 19:59:52 +0000 Superior clinical research - another example Radiant completes first
    Message 1 of 1 , Aug 31, 2005
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      -----Original Message-----
      From: - V I N - <vivisectionkills@...>

      Date: Wed, 31 Aug 2005 19:59:52 +0000

      Superior clinical research - another example

      Radiant completes first (14) Carbon microdosing study

      By Wai Lang Chu

      29/08/2005 - The first (14) Carbon microdosing study to take place in
      United States has been completed by Radiant Research, who believe this
      approach to clinical trials will lead to more accurate and earlier
      pharmacokinetic (PK) data on drug candidates than is currently possible
      through conventional development strategies.

      "Microdosing or 'Phase 0' studies can be done much earlier than
      Phase I studies, thereby reducing attrition in clinical development.
      will ensure that limited resources are focused on the best drug
      potentially saving several years and millions of dollars," said Michael
      Lester, chief executive officer of Radiant Research.

      The study re-evaluated the drug azidothymidine (AZT), at
      "nanodose" concentrations (520 nanograms) isotopically labelled with
      (14)Carbon. This dose is approximately one million fold lower than the
      recommended daily dose in patients and would be impossible to detect by
      traditional analytic methods.

      In partnership with Vitalea Science, Radiant Research utilised the
      Accelerator Mass Spectrometry (AMS) technique - currently the most

      analytical tool to enter the drug development market place.

      With AMS technology, Vitalea scientists were able to quantify AZT
      concentrations in blood, urine, saliva, white blood cells, and even DNA
      white blood cells for more than 72 hours after administering the drug to
      human subject.
      "The completion of this study is a remarkable milestone for drug
      development," said Jon Ruckle, medical director of early phase clinical
      research at Radiant Research.

      "The study not only validates our ability to conduct microdosing trials,

      also demonstrates the utility of this tool in gathering human PK

      about drugs at sub-therapeutic, sub-toxic doses very early in the
      development cycle," he added.
      "We chose AZT for this joint project because it is a prime example of
      dual nature of a drug," said Stephen Dueker, President of Vitalea

      "AZT carries some risk at therapeutic doses despite its proven ability
      reduce HIV viral loads. Indeed, there is no safe and ethical way to

      this drug at therapeutic doses in healthy volunteers," he added.

      The FDA has sent out a strong call asking for the pharmaceutical
      industry to

      modernise the clinical components of drug selection and development.
      adoption of microdosing using AMS Technology has been one of many
      to this ongoing problem.

      As many as one in three drugs fail in Phase I (healthy volunteer)
      testing despite extensive pre-clinical screening of potential clinical
      candidates with a wide variety of in silico, in vitro, ex-vivo and

      A high proportion of these failures can be attributed to sub-optimal
      pharmacokinetics (PK) leading to potential efficacy or safety issues in

      Another company heavily involved with microdosing is Xceleron, who in
      September 2004, struck a deal with GlaxoSmithKline GSK) which has
      in the drug giants commissioning the pharmaceutical industry's first
      in-house Accelerator Mass Spectrometry (AMS) facility.

      Animal experiments have:
      a 63% failure rate when detecting human carcinogens
      a 75-95% failure rate for detecting drug side effects
      a 70% failure rate for detecting drugs which cause birth defects
      Success rates lower than those achieved by uneducated guesswork.

      This is not science!!
      Recommended website: The Absurdity of vivisection
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