Research Topics
| Frank DieterleSummaryAffiliation: Novartis Institutes for BioMedical Research Publications
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Detail Information
Publications
Monitoring kidney safety in drug development: emerging technologies and their implicationsFrank Dieterle
Novartis Pharma AG, Klybeckstrasse 141, CH 4057 Basel, Switzerland
Curr Opin Drug Discov Devel 11:60-71. 2008..Finally, the associated regulatory processes for use in clinics are also discussed...
Urinary clusterin, cystatin C, beta2-microglobulin and total protein as markers to detect drug-induced kidney injuryFrank Dieterle
Novartis Institutes for BioMedical Research, Novartis, Basel, Switzerland
Nat Biotechnol 28:463-9. 2010..The recognition of the qualification of these biomarkers by the EMEA and FDA will significantly enhance renal safety monitoring...
Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing ConsortiumFrank Dieterle
Novartis Pharma AG, Basel, Switzerland
Nat Biotechnol 28:455-62. 2010....
New technologies around biomarkers and their interplay with drug developmentFrank Dieterle
Novartis Pharma AG, Development, 4002, Basel, Switzerland
Anal Bioanal Chem 390:141-54. 2008..The roles as well as the pros and cons of different disciplines such as genetics, genomics, proteomics, metabonomics, and assay development will be discussed...
Impact of biomarker development on drug safety assessmentEstelle Marrer
Translational Sciences, Novartis Institutes for BioMedical Research, CH 4002 Basel, Switzerland
Toxicol Appl Pharmacol 243:167-79. 2010..A last part will be dedicated to safety biomarker development in general, from identification to diagnostic tests, using the kidney safety biomarkers success as an illustrative example...
Promises of biomarkers in drug development--a reality checkEstelle Marrer
Novartis Pharma AG, Development, 4002 Basel, Switzerland
Chem Biol Drug Des 69:381-94. 2007..Besides discussing their perspectives of applications, the present article also illustrates the future of biomarker development in terms of qualification for regulatory use and co-development...
Biomarkers in oncology drug development: rescuers or troublemakers?Estelle Marrer
Novartis Institutes for BioMedical Research, Translational Sciences, Novartis, Klybeckstr 141, CH 4002 Basel, Switzerland
Expert Opin Drug Metab Toxicol 4:1391-402. 2008....
Tissue-specific, non-invasive toxicity biomarkers: translation from preclinical safety assessment to clinical safety monitoringPatrick Y Muller
Novartis Institutes for BioMedical Research, Basel, Switzerland
Expert Opin Drug Metab Toxicol 5:1023-38. 2009..In addition, the current regulatory status is presented and discussed in view of recent changes in regulatory acceptance by health authorities...
Application of metabonomics in a comparative profiling study reveals N-acetylfelinine excretion as a biomarker for inhibition of the farnesyl pathway by bisphosphonatesFrank Dieterle
Pharmaceuticals Division, F Hoffman La Roche Ltd, 4070 Basel, Switzerland
Chem Res Toxicol 20:1291-9. 2007..This is the reported mode of action of bisphosphonates. Until now, N-acetylfelinine was exclusively observed in the urine of felidae species, where it is believed to be a precursor to a pheromone...
Application of metabonomics in a compound ranking study in early drug development revealing drug-induced excretion of choline into urineFrank Dieterle
F. Hoffmann-La Roche Ltd, Pharmaceuticals Division, PRBD-E, Building 065/512, 4070-Basel, Switzerland
Chem Res Toxicol 19:1175-81. 2006....
Urinary nucleosides as potential tumor markers evaluated by learning vector quantizationFrank Dieterle
Institute of Physical and Theoretical Chemistry, Auf der Morgenstelle 8, D 72076 Tubingen, Germany
Artif Intell Med 28:265-79. 2003..As at least some of these features play an important role in an implementation into a medical decision support system, it is recommended to use LVQ for an extended study...
