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Lutz Harnisch
Lutz Harnisch
Regeneron, Executive Director, Head Quantitative Pharmacology
Verifierad e-postadress på regeneron.com
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Good practices in model‐informed drug discovery and development: practice, application, and documentation
EFPIA MID3 Workgroup, SF Marshall, R Burghaus, V Cosson, ...
CPT: pharmacometrics & systems pharmacology 5 (3), 93-122, 2016
2572016
Lack of efficacy of the selective iNOS inhibitor GW274150 in prophylaxis of migraine headache
HO Høivik, BE Laurijssens, LO Harnisch, CK Twomey, RM Dixon, ...
Cephalalgia 30 (12), 1458-1467, 2010
902010
Drug and disease model resources: a consortium to create standards and tools to enhance model‐based drug development
L Harnisch, I Matthews, J Chard, MO Karlsson
CPT: Pharmacometrics & Systems Pharmacology 2 (3), 1-3, 2013
472013
Modeling and simulation as a tool to bridge efficacy and safety data in special populations
L Harnisch, T Shepard, G Pons, O Della Pasqua
CPT: pharmacometrics & systems pharmacology 2 (2), 1-4, 2013
452013
Pharmacometrics Markup Language (PharmML): opening new perspectives for model exchange in drug development
MJ Swat, S Moodie, SM Wimalaratne, NR Kristensen, M Lavielle, A Mari, ...
CPT: pharmacometrics & systems pharmacology 4 (6), 316-319, 2015
412015
Population kinetics of gentamicin in neonates
W Weber, G Kewitz, KL Rost, M Looby, M Nitz, L Harnisch
European Journal of Clinical Pharmacology 44, S23-S25, 1993
401993
Elucidation of factor VIII activity pharmacokinetics: a pooled population analysis in patients with hemophilia A treated with moroctocog alfa
JA Abrantes, EI Nielsen, J Korth‐Bradley, L Harnisch, S Jönsson
Clinical Pharmacology & Therapeutics 102 (6), 977-988, 2017
282017
Advancing clinical trial design in pulmonary hypertension
AP Grieve, SC Chow, J Curram, S Dawe, LO Harnisch, NR Henig, ...
Pulmonary circulation 3 (1), 217-225, 2013
252013
Application of quantitative pharmacology approaches in bridging pharmacokinetics and pharmacodynamics of domagrozumab from adult healthy subjects to pediatric patients with …
I Bhattacharya, Z Manukyan, P Chan, A Heatherington, L Harnisch
The Journal of Clinical Pharmacology 58 (3), 314-326, 2018
212018
Efficacy and tolerability of the iNOS inhibitor GW274150 administered up to 120 mg daily for 12 weeks in the prophylactic treatment of migraine
K Hoye, BE Laurijssens, LO Harnisch, CK Twomey, RM Dixon, A Kirkham
Cephalalgia 29 (1), 132, 2009
212009
Efficacy of 1, 5, and 20 mg oral sildenafil in the treatment of adults with pulmonary arterial hypertension: a randomized, double-blind study with open-label extension
CD Vizza, BKS Sastry, Z Safdar, L Harnisch, X Gao, M Zhang, M Lamba, ...
BMC pulmonary medicine 17, 1-12, 2017
192017
Towards regulatory endorsement of drug development tools to promote the application of model-informed drug development in Duchenne muscular dystrophy
DJ Conrado, J Larkindale, A Berg, M Hill, J Burton, KR Abrams, ...
Journal of pharmacokinetics and pharmacodynamics 46, 441-455, 2019
172019
Lessons learned from a phase III population pharmacokinetic study of cariporide in coronary artery bypass graft surgery
W Weber, L Harnisch, A Jessel
Clinical Pharmacology & Therapeutics 71 (6), 457-467, 2002
172002
Use of a population pharmacokinetic model to predict clinical outcome of leflunomide, a new DMARD in the treatment of rheumatoid arthritis.
W Weber, L Harnisch
ARTHRITIS AND RHEUMATISM 40 (9), 731-731, 1997
141997
Model description language (MDL): a standard for modeling and simulation
MK Smith, SL Moodie, R Bizzotto, E Blaudez, E Borella, L Carrara, ...
CPT: pharmacometrics & systems pharmacology 6 (10), 647, 2017
122017
Making every subject count: a case study of drug development path for medication in a pediatric rare disease
I Bhattacharya, Z Manukyan, P Chan, L Harnisch, A Heatherington
Clinical Pharmacology & Therapeutics 100 (4), 330-332, 2016
112016
Modeling of survival and frequency of cardiovascular-related hospitalization in patients with transthyretin amyloid cardiomyopathy treated with tafamidis
C Vong, M Boucher, S Riley, LO Harnisch
American Journal of Cardiovascular Drugs 21, 535-543, 2021
102021
The population approach: measuring and managing variability in response, concentration and dose
W Weber, L Harnisch
COST B1 medicine: European cooperation in the field of scientific and …, 1997
81997
The effect of activated charcoal and cholestyramine on the pharmacokinetics of leflunomide
HJ Roethig, J Collins, L Harnisch, C Rokitta, W Weber
Clinical Pharmacology & Therapeutics 59 (2), 204-204, 1996
81996
Thoughtflow: standards and tools for provenance capture and workflow definition to support model‐informed drug discovery and development
JJ Wilkins, PLS Chan, J Chard, G Smith, MK Smith, M Beer, A Dunn, ...
CPT: Pharmacometrics & Systems Pharmacology 6 (5), 285-292, 2017
62017
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Artiklar 1–20