Meeting Report: Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit
Journal Title: The AAPS Journal - Year 2010, Vol 12, Issue 3
Abstract
The online version of this article (doi:10.1208/s12248-010-9206-0) contains supplementary material, which is available to authorized users.
Authors and Affiliations
Arzu Selen, Maria T. Cruañes, Anette Müllertz, Paul A. Dickinson, Jack A. Cook, James E. Polli, Filippos Kesisoglou, John Crison, Kevin C. Johnson, Gordon T. Muirhead, Timothy Schofield, Yi Tsong
Pharmacodynamics of Telomerase Inhibition and Telomere Shortening by Noncytotoxic Suramin
We reported that suramin is an effective chemosensitizer at noncytotoxic concentrations (<50 μM); this effect was observed in multiple types of human xenograft tumors in vitro and in vivo. Clinical evalua...
Mechanistic Modeling of Monocarboxylate Transporter-Mediated Toxicokinetic/Toxicodynamic Interactions Between γ-Hydroxybutyrate and l -Lactate
Overdose of γ-hydroxybutyrate (GHB) can result in severe respiratory depression. Monocarboxylate transporter (MCT) inhibitors, including l -lactate, increase GHB clearance and represent a potential treatment for...
Protein aggregation and bioprocessing
Protein aggregation is a common issue encountered during manufacture of biotherapeutics. It is possible to influence the amount of aggregate produced during the cell culture and purification process by carefully controll...
Development of a Novel Oral Cavity Compartmental Absorption and Transit Model for Sublingual Administration: Illustration with Zolpidem
The online version of this article (doi:10.1208/s12248-015-9727-7) contains supplementary material, which is available to authorized users.
Population Pharmacokinetics of Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir, and Ribavirin in Patients with Hepatitis C Virus Genotype 1 Infection: Combined Analysis from 9 Phase 1b/2 Studies
Direct-acting antiviral agents (DAAs) are established as the standard of care for chronic hepatitis C virus (HCV) infection. One of the newest additions to the HCV arsenal is an oral three-DAA combination therapy (i.e.,...