Establishing Virtual Bioequivalence and Clinically Relevant Specifications for Omeprazole Enteric-Coated Capsules by Incorporating Dissolution Data in PBPK Modeling.

Currently, Biopharmaceutics Classification System (BCS) classes I and III are the only biological exemptions of immediate-release solid oral dosage forms eligible for regulatory approval. However, through virtual bioequivalence (VBE) studies, BCS class II drugs may qualify for biological exemptions if reliable and validated modeling is used. Here, we sought to establish physiologically based pharmacokinetic (PBPK) models, in vitro-in vivo relationship (IVIVR), and VBE models for enteric-coated omeprazole capsules, to establish a clinically-relevant dissolution specification (CRDS) for screening BE and non-BE batches, and to ultimately develop evaluation criteria for generic omeprazole enteric-coated capsules.

Rapid Detection and Quantification of Viable Cells of Using Propidium Monoazide Combined with Real-Time PCR.

() has caused significant economic losses in major vegetable production areas in Northern China by causing bacterial soft rot in cash crops such as potatoes and cucumbers. This study aimed to establish a PMA-qPCR detection method for by screening specific and sensitive primers based on the gene and the conserved region of the 23S rRNA gene. Based on the optimized PMA pretreatment conditions, a standard curve was designed and constructed for PMA-qPCR detection (y = -3.

Association between pulse wave velocity and hot flashes/sweats in middle-aged women.

As women age and go through menopause, they suffer a higher incidence of cardiovascular morbidity and mortality. Previous studies have shown that a relationship exists between hot flashes/sweats and an increased risk of cardiovascular disease. However, the association between hot flashes/sweats and arterial stiffness is unclear.

Sleep disorder, an independent risk associated with arterial stiffness in menopause.

As women age and go through menopause, they suffer a higher incidence of sleep disorder, cardiovascular morbidity and mortality. In addition, evidences suggested that sleep disorder was an important pathological indicator for coronary heart disease. However, the relationship between different menopausal status, sleep disorder and cardiovascular diseases was unclear.