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
Mechanistic Toxicokinetic Model for γ-Hydroxybutyric Acid: Inhibition of Active Renal Reabsorption as a Potential Therapeutic Strategy
γ-Hydroxybutyric acid (GHB), a drug of abuse, exhibits saturable renal clearance and capacity-limited metabolism. The objectives of this study were to construct a mechanistic toxicokinetic (TK) model describing s...
Regional-Dependent Intestinal Permeability and BCS Classification: Elucidation of pH-Related Complexity in Rats Using Pseudoephedrine
Based on its lower Log P value relative to metoprolol, a marker for the low/high-permeability (Peff) class boundary, pseudoephedrine was provisionally classified as BCS low-permeability compound. On the other hand, follo...
A mucoadhesive, cyclodextrin-based vaginal cream formulation of itraconazole
The development of vaginal medications, especially antifungal medications, requires that the drug is solubilized as well as retained at or near the mucosa for sufficient periods of time to ensure adequate bioavailability...
Population Analyses of Efficacy and Safety of ABT-594 in Subjects with Diabetic Peripheral Neuropathic Pain
ABT-594, a neuronal nicotinic acetylcholine receptor ligand, is 30- to 100-fold more potent than morphine in animal models of nociceptive and neuropathic pain. Efficacy and safety of ABT-594 in subjects with painful diab...
Statistics on BCS Classification of Generic Drug Products Approved Between 2000 and 2011 in the USA
The Biopharmaceutics Classification system (BCS) classifies drug substances based on aqueous solubility and intestinal permeability. The objective of this study was to use the World Health Organization Model List of Esse...