Affiliation: Novartis Institutes for BioMedical Research
- 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...
- Metabolic profiling technologies for biomarker discovery in biomedicine and drug developmentGötz Schlotterbeck
F Hoffmann La Roche Ltd, Pharmaceuticals Division, PRBD E, CH 4070 Basel, Switzerland
Pharmacogenomics 7:1055-75. 2006..The complexity of disease and drug treatment is asking for an adequate response by integrated and comprehensive metabolite profiling approaches that allow the discovery of new combinations of metabolic biomarkers...
- 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...