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
Metrics for the Evaluation of Bioequivalence of Modified-Release Formulations
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In the search for a radioligand capable of imaging cannabinoid CB1 receptors in the living human brain by SPECT (single photon emission computed tomography), N-(morpholin-4-yl)-1-(2,4-dichlorophenyl)-5-(4-iodophenyl)-4-m...
Points to Consider when Establishing Drug Product Specifications for Parenteral Microspheres
Drug product specifications are a critical element of a good control strategy. Parenteral microsphere products are complex dosage forms, requiring careful development of test methods and acceptance criteria for the speci...
Predicting Pediatric Age-Matched Weight and Body Mass Index
The online version of this article (doi:10.1208/s12248-014-9657-9) contains supplementary material, which is available to authorized users.
Summary of Confirmation Cut Point Discussions
A subgroup of AAPS NBC Immunogenicity Workshop attendees met to discuss the current recommendations in white papers and guidance documents, to describe and discuss current practices, and to resolve concerns as to the bio...