Erratum to: Dissolution Similarity Requirements: How Similar or Dissimilar Are the Global Regulatory Expectations?
Journal Title: The AAPS Journal - Year 2016, Vol 18, Issue 3
Abstract
Authors and Affiliations
Dorys Argelia Diaz, Stephen T. Colgan, Connie S. Langer, Nagesh Bandi, Michael D. Likar, Leslie Van Alstine
Keywords
Related Articles
- EP ID EP680887
- DOI 10.1208/s12248-015-9835-4
- Views 35
- Downloads 0
Pharmacodynamic parameter estimation: Population size versus number of samples
The purpose of this study was to evaluate the effects of population size, number of samples per individual, and level of interindividual variability (IIV) on the accuracy and precision of pharmacodynamic (PD) parameter e...
Study Reanalysis Using a Mechanism-Based Pharmacokinetic/Pharmacodynamic Model of Pramlintide in Subjects with Type 1 Diabetes
This report describes a pharmacokinetic/pharmacodynamic model for pramlintide, an amylinomimetic, in type 1 diabetes mellitus (T1DM). Plasma glucose and drug concentrations were obtained following bolus and 2-h intraveno...
Repeat Analysis and Incurred Sample Reanalysis: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team
The A7 harmonization team (A7 HT), a part of the Global Bioanalysis Consortium (GBC), focused on reviewing best practices for repeat analysis and incurred sample reanalysis (ISR) as applied during regulated bioanalysis....
CNS drug delivery: Opioid peptides and the blood-brain barrier
Peptides are key regulators in cellular and intercellular physiological responses and possess enormous promise for the treatment of pathological conditions. Opioid peptide activity within the central nervous system (CNS)...
Universal Immunoassay Applied During Early Development of Large Molecules to Understand Impact of Immunogenicity on Biotherapeutic Exposure
The online version of this article (doi:10.1208/s12248-012-9403-0) contains supplementary material, which is available to authorized users.