Characterization of dose-response for count data using a generalized MCP-Mod approach in an adaptive dose-ranging trial.

Mercier, Francois; Bornkamp, Bjoern; Ohlssen, David; Wallstroem, Erik

Mercier, Francois; Bornkamp, Bjoern; Ohlssen, David; Wallstroem, Erik.

Affiliation

Mercier F; F. Hoffmann-La Roche Ltd., Clinical Pharmacology, Basel, Switzerland.
Bornkamp B; Novartis Pharma AG, Basel, Switzerland.
Ohlssen D; Novartis Pharmaceutical, East Hanover, NJ, USA.
Wallstroem E; Novartis Pharma AG, Basel, Switzerland.

Pharm Stat ; 14(4): 359-67, 2015.

Article in En | MEDLINE | ID: mdl-26083135

Subject(s)

Clinical Trials, Phase II as Topic/statistics & numerical data; Dose-Response Relationship, Drug; Research Design/statistics & numerical data; Clinical Trials, Phase II as Topic/methods; Computer Simulation; Data Interpretation, Statistical; Humans; Immunologic Factors/administration & dosage; Linear Models; Magnetic Resonance Imaging; Multiple Sclerosis, Relapsing-Remitting/diagnosis; Multiple Sclerosis, Relapsing-Remitting/drug therapy; Nonlinear Dynamics; Time Factors; Treatment Outcome; Uncertainty

Key words

Emax model; dose-finding; multiple sclerosis; non-linear regression; optimal design; two-stage design

Fulltext

XML

PubMed Links

Search on Google

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Research Design / Clinical Trials, Phase II as Topic / Dose-Response Relationship, Drug Type of study: Diagnostic_studies / Prognostic_studies Limits: Humans Language: En Journal: Pharm Stat Journal subject: FARMACOLOGIA Year: 2015 Type: Article Affiliation country: Switzerland

Fulltext

XML

PubMed Links

Search on Google