The Role of Enhanced Analytical Procedure Development in Facilitating Post-Approval Changes Via Established Conditions.

Enabling greater flexibility for lifecycle management of analytical procedures is one of the primary features of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 Lifecycle Management guideline. Rather than rely on a comparatively slower and burdensome post-approval change supplement process, ICH Q12 created a new pathway to facilitate changes to chemistry, manufacturing, and controls. The new framework utilized key concepts such as established conditions (ECs), post-approval change management protocols, and the product lifecycle management document to allow modifications to analytical procedures based upon pre-approved conditions.

Trigeminal nerve stimulation in drug-resistant epilepsy: A systematic review.

Introduction: Trigeminal Nerve Stimulation (TNS) is a technique that may be useful to reduce seizure burden in drug-resistant epilepsy (DRE), but its efficacy is not well characterized. This study sought to understand the application of TNS in DRE by providing a comprehensive overview of the current use and efficacy of TNS for neuromodulation in DRE.

Methods: A systematic review examining the use of TNS for DRE was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.

Sustainable groundwater management through water quality index and geochemical insights in Valsad India.

Groundwater quality assessment is crucial for sustainable water resource management and public health protection. This study evaluated the Water Quality Index (WQI) of groundwater in the southern part of Gujarat focusing on the Valsad District. Groundwater in this region occurs in porous, unconsolidated formations and fracture formations, both under groundwater table conditions and confined aquifers.

Assessment of Food Effect and pH-Dependent Drug-Drug Interactions of Fruquintinib in Healthy Subjects.

This two-sequence, three-period study (NCT04645940) was designed to evaluate the effect of food and concomitant rabeprazole, a proton pump inhibitor, on the pharmacokinetics (PK) and safety of fruquintinib and its metabolite M11 after a single oral dose of fruquintinib 5 mg in healthy subjects. In the food effect treatment periods, 14 subjects were randomized in a 1:1 ratio utilizing a two-sequence (fed/fasted vs. fasted/fed), two-period, cross-over design.

Distinct features of a peripheral T helper subset that drives the B cell response in dengue virus infection.

Dengue-virus-induced humoral immunity can increase the risk of severe disease, but the factors influencing this response are poorly understood. Here, we investigate the contribution of CD4 T cells to B cell responses in human dengue infection. We identify a dominant peripheral PD-1 T cell subset that accumulates in severe patients and could induce B cell differentiation via interleukin-21 (IL-21)-related pathway.