The Coulter Principle for Analysis of Subvisible Particles in Protein Formulations
Journal Title: The AAPS Journal - Year 2011, Vol 13, Issue 1
Abstract
The Coulter principle can be used for analysis of subvisible particles in protein formulations. The approach has several advantages including: an orthogonal operating principle, high sensitivity, ability to detect very small particles, excellent reproducibility, and high-resolution size information. This minireview discusses some of the important considerations that must be taken into account when utilizing the Coulter principle for subvisible particle analysis in protein formulations.
Authors and Affiliations
Matthew N. Rhyner
Performance of Three Estimation Methods in Repeated Time-to-Event Modeling
It is not uncommon that the outcome measurements, symptoms or side effects, of a clinical trial belong to the family of event type data, e.g., bleeding episodes or emesis events. Event data is often low in information co...
A Markov Chain Model to Evaluate the Effect of CYP3A5 and ABCB1 Polymorphisms on Adverse Events Associated with Tacrolimus in Pediatric Renal Transplantation
The SNP A6986G of the CYP3A5 gene (*3) results in a non-functional protein due to a splicing defect whereas the C3435T was associated with variable expression of the ABCB1 gene, due to protein instability. Part of the la...
Summary Workshop Report: Facilitating Oral Product Development and Reducing Regulatory Burden Through Novel Approaches to Assess Bioavailability/Bioequivalence
This summary workshop report highlights presentations and over-arching themes from an October 2011 workshop. Discussions focused on best practices in the application of biopharmaceutics in oral drug product development a...
Comparison of the rates of deamidation, diketopiperazine formation, and oxidation in recombinant human vascular endothelial growth factor and model peptides
In this work, we examine the way in which stability information obtained from studies on small model peptides correlates with similar information acquired from a protein. The rates of deamidation, oxidation, and diketopi...
Endocannabinoid signaling directs periimplantation events
An emerging concept in female reproduction is the role of endocannabinoids, a group of endogenously produced lipid mediators that bind to and activate cannabinoid receptors. Although adverse effects of cannabinoids in fe...