The reaction of sulfhydryl (SH)-containing molecules (thiols) with S-nitrosothiols (RSNO) has been shown to be of biological importance. Biologically or therapeutically relevant thiols generally have a pKa value ranging...
Simulation of gastrointestinal conditions is essential to adequately predict the in vivo behavior of drug formulations. To reduce the size and number of human studies required to identify a drug product with appropriate...
Throughout the life cycle of biopharmaceutical products, bioanalytical support is provided using ligand binding assays to measure the drug product for pharmacokinetic, pharmacodynamic, and immunogenicity studies. The spe...
The importance of appropriate sample management in regulated bioanalysis is undeniable for clinical and non-clinical study support due to the fact that if the samples are compromised at any stage prior to analysis, the s...
The similarity factor, f2, measures the sameness of dissolution profiles. The following commentary is an overview of discussions and presentations from a group of industry and US regulatory experts that have integrated t...
The kinetics of thiol-mediated decomposition of S-nitrosothiols
The reaction of sulfhydryl (SH)-containing molecules (thiols) with S-nitrosothiols (RSNO) has been shown to be of biological importance. Biologically or therapeutically relevant thiols generally have a pKa value ranging...
The Use of Biorelevant Dissolution Media to Forecast the In Vivo Performance of a Drug
Simulation of gastrointestinal conditions is essential to adequately predict the in vivo behavior of drug formulations. To reduce the size and number of human studies required to identify a drug product with appropriate...
Critical ligand binding reagent preparation/selection: When specificity depends on reagents
Throughout the life cycle of biopharmaceutical products, bioanalytical support is provided using ligand binding assays to measure the drug product for pharmacokinetic, pharmacodynamic, and immunogenicity studies. The spe...
Sample Management: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team
The importance of appropriate sample management in regulated bioanalysis is undeniable for clinical and non-clinical study support due to the fact that if the samples are compromised at any stage prior to analysis, the s...
Scientific and Regulatory Standards for Assessing Product Performance Using the Similarity Factor, f2
The similarity factor, f2, measures the sameness of dissolution profiles. The following commentary is an overview of discussions and presentations from a group of industry and US regulatory experts that have integrated t...