Ontology highlight
ABSTRACT:
SUBMITTER: Lamba M
PROVIDER: S-EPMC5485720 | biostudies-literature | 2017 Jun
REPOSITORIES: biostudies-literature
Lamba M M Hutmacher M M MM Furst D E DE Dikranian A A Dowty M E ME Conrado D D Stock T T Nduaka C C Cook J J Krishnaswami S S
Clinical pharmacology and therapeutics 20170209 6
Extended-release (XR) formulations enable less frequent dosing vs. conventional (e.g., immediate release (IR)) formulations. Regulatory registration of such formulations typically requires pharmacokinetic (PK) and clinical efficacy data. Here we illustrate a model-informed, exposure-response (E-R) approach to translate controlled trial data from one formulation to another without a phase III trial, using a tofacitinib case study. Tofacitinib is an oral Janus kinase (JAK) inhibitor for the treatm ...[more]