Therapeutic Drug Monitoring in Clinical Trials by rub18840


                                                                            A Eurofins Medinet quarterly newsletter

Therapeutic Drug Monitoring in Clinical Trials
One of the most important pharmacokinetic properties of       the serum or plasma drug concentrations to ensure drug
a drug is the availability of the active drug metabolite in   effectiveness and patient safety. For instance, patients
the systemic circulation of a patient. However, many drugs    with renal failure who suffer from impaired clearance of a
are being administered orally and numerous influences         drug with a narrow therapeutic index should be monitored
reduce the bioavailability of the drug. Some examples         closely.
of these influences include properties of the drug itself
(e.g. solubility), if the drug is administered in a fed or    Eurofins Medinet offers quantitative measurement of
fasted state, and interactions or inhibition of the drug.     small molecule and biotherapeutic drug compounds and
Furthermore, drug metabolism may vary from person to          or their metabolites from early development to clinical PK
person, and sometimes even in the same person over time.      as well as therapeutic drug monitoring integrated within
                                                              clinical trials in an “everyday
Eurofins Medinet performs pharmacokinetic profiling           safety testing setting”
in phase I and II enabling to determine the correlation       common to a central
between the drug’s therapeutic effect and the                 laboratory routine. We
administered dosage of the drug. For some drugs under         monitor the patient’s
investigation, a variation in bioavailability has been        safety and provide
observed. If these drugs also have a narrow therapeutic       crucial information
index -meaning that therapeutic drug levels do not differ     to the investigator for
greatly from the levels associated with toxicity or adverse   dosing determination.
reactions- there is a great need for regularly measuring

                                  Eurofins Medinet strengthens
                                  Washington DC Leadership Team
                                  Eurofins Medinet is pleased to announce the employment of Kevin Smith, BSc, MBA
                                  as Director of Central Laboratory Operations on December 1, 2008. Mr. Smith will lead
                                  the central laboratory operations at the Eurofins Medinet laboratory in Washington DC
                                  and brings over 8 years of experience working in laboratories and clinical research
                                  facilities, and most recently as the CRO Manager – Outsourcing for Novartis Pharma in
                                  Basel, Switzerland.
Kevin Smith

               Microbiology Laboratory Testing at Eurofins Medinet
               Eurofins Medinet Breda is pleased to announce that new          teams of both Eurofins Medinet Washington DC and
               microbiology testing capabilities have been initiated to        Eurofins Medinet Paris, the Breda team will work hand
               conduct organism identification and MIC susceptibility          in hand with leading microbiologists at the Eurofins
               testing in the near future. Joining the anti-infective          Medinet Washington DC facility to ensure the highest
                                                                               quality standards for our clients. Along with the Eurofins
                                                                               Medinet Paris microbiology lab, the new microbiology
                                                                               lab in Breda will support global clinical trials that require
                                                                               clinical microbiology testing in Europe. Eurofins Medinet
                                                                               Washington DC center of excellence in microbiology
                                                                               testing is lead by Dr. Dan Sahm, with critical support
                                                                               from Drs. Clyde Thornsberry, Doug Toal, and Chris
                                                                               Pillar. It conducts specialized microbiology testing and
                                                                               surveillance, and provides consultation for all phases
                                                                               of drug development, including pre clinical and post
                                                                               marketing programs.

               Mark your meeting calender
               and visit us at the following conferences

               Partnering with Central Labs, ECG and Imaging Labs              Immunogenicity for Biologics 2009
               26-28 January 2009, Las Vegas, USA                              9-13 February 2009, Berlin, Germany
               Booth # 302                                                     Booth # 3

               Biomarker Assay Development                                     4th Annual Biomarker Congress
               26-28 January 2009, San Diego, USA                              26-27 February 2009, Manchester, UK

               CEMO                                                            BIO-Europe Spring 2009
               29 January 2009, Paris, France                                  16-18 March 2009, Milan, Italy
               Booth # M16

               If you have any questions or suggestions, please feel free to contact us via
               or contact your representative.

               Eurofins Medinet                 Breda               tel +31 (0)76 572 72 72
                                                Paris               tel +33 (0)1 3054 6000
                                                Washington DC       tel +1 866 324 8691
NEWS 0109-08

                                                Denver              tel +1 720 961 4488
              Singapore           tel +65 6562 3858
               Shanghai            tel +86 512 6680 1266

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