Erratum to: A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion
Journal Title: The AAPS Journal - Year 2015, Vol 17, Issue 6
Abstract
The online version of the original article can be found at 10.1208/s12248-015-9753-5.
Authors and Affiliations
Wenlei Jiang, Fairouz Makhlouf, Donald J. Schuirmann, Xinyuan Zhang, Nan Zheng, Dale Conner, Lawrence X. Yu, Robert Lionberger
Keywords
Related Articles
- EP ID EP681033
- DOI 10.1208/s12248-015-9786-9
- Views 63
- Downloads 0
A Whole-Body Physiologically Based Pharmacokinetic Model of Gefitinib in Mice and Scale-Up to Humans
Gefitinib (Iressa) is a selective and potent EGFR tyrosine kinase inhibitor. It received an accelerated FDA approval in 2003 for the treatment of patients with nonsmall cell lung cancer (NSCLC) and represents the first-l...
A guide for reporting the results of population pharmacokinetic analyses: A Swedish perspective
Population pharmacokinetic analyses are frequently part of regulatory submissions and are mainly used to provide information on special populations (effects of age, renal impairment, etc) and drug-drug interactions. A va...
Selectivity and potency of cyclin-dependent kinase inhibitors
Members of the cyclin-dependent kinase (CDK) family play key roles in various cellular processes. There are 11 members of the CDK family known till now. CDKs are activated by forming noncovalent complexes with cyclins su...
Early Drug Discovery Prediction of Proarrhythmia Potential and Its Covariates
Prediction of Exposure–Response Relationships to Support First-in-Human Study Design
In drug development, phase 1 first-in-human studies represent a major milestone as the drug moves from preclinical discovery to clinical development activities. The safety of human subjects is paramount to the conduct of...