Assessing the similarity of dose response and target doses in two non-overlapping subgroups

Author:

Bretz Frank12ORCID,Möllenhoff Kathrin3,Dette Holger3,Liu Wei4,Trampisch Matthias5

Affiliation:

1. Novartis Pharma AG; Basel CH-4002 Switzerland

2. Center for Medical Statistics, Informatics and Intelligent Systems; Medical University of Vienna; Vienna Austria

3. Department of Mathematics; Ruhr-Universität Bochum; Germany

4. S3RI and School of Mathematics; University of Southampton; Southampton, SO17 1TB UK

5. Boehringer Ingelheim Pharma GmbH & Co. KG; Biostatistics + Data Sciences / BDS; Germany

Funder

G. Harold and Leila Y. Mathers Charitable Foundation

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference33 articles.

1. Dose response studies I. Some design considerations;Ruberg;J Biopharm Stat,1995

2. ICH Harmonized Tripartite Guideline Topic E4: Dose-response information to support drug registration http://www.ich.org/home.html 1994

3. Similarity of insulin detemir pharmacokinetics, safety, and tolerability profiles in healthy Caucasian and Japanese American subjects;Jhee;The J Clin Pharmacol,2004

4. Comparative analysis of the uterine and mammary gland effects of drospirenone and medroxyprogesterone acetate;Otto;Endocrinology,2008

5. Innovative approaches for designing and analyzing adaptive dose-ranging trials;Bornkamp;J Biopharm Stat,2007

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