Biopharmaceutics Applications of Physiologically Based Pharmacokinetic Absorption Modeling and Simulation in Regulatory Submissions to the U.S. Food and Drug Administration for New Drugs.

Physiologically based pharmacokinetic (PBPK) absorption modeling and simulation is increasingly used as a tool in drug product development, not only in support of clinical pharmacology applications (e.g., drug-drug interaction, dose selection) but also from quality perspective, enhancing drug product understanding.

Mucuna pruriens (L.) DC chemo sensitize human breast cancer cells via downregulation of prolactin-mediated JAK2/STAT5A signaling.

Ethnopharmacological Relevance: Mucuna pruriens (L.) DC (MP) is an ancient Indian medicinal plant traditionally used to treat Parkinson's disease. L-Dopa (LD), precursor of dopamine is abundantly found in the seeds of MP.

Parental High-Fat Diet Promotes Inflammatory and Senescence-Related Changes in Prostate.

. Obesity and dietary habits are associated with increased incidences of aging-related prostatic diseases. The present study was aimed to investigate transgenerational effects of chronic high-fat diet (HFD) feeding on inflammation and senescence-related changes in prostate.

c-Myc-Dependent Cell Competition in Human Cancer Cells.

Cell Competition is an interaction between cells for existence in heterogeneous cell populations of multicellular organisms. This phenomenon is involved in initiation and progression of cancer where heterogeneous cell populations compete directly or indirectly for the survival of the fittest based on differential gene expression. In Drosophila, cells having lower dMyc expression are eliminated by cell competition through apoptosis when present in the milieu of cells having higher dMyc expression.

Direct detection of phenylephrine 3-O-sulfate in LS180 human intestinal cells using a novel hydrophilic interaction liquid chromatography (HILIC) assay.

The efficacy of phenylephrine (PE) is controversial due to its extensive pre-systemic metabolism through sulfation to form phenylephrine-3-O-sulfate (PES). Hence quantitation of PES is important in order to study the metabolism of PE. There are no published methods available for direction detection of PES.

Regulatory Experience with In Vivo In Vitro Correlations (IVIVC) in New Drug Applications.

In the past two decades, in vitro in vivo correlation (IVIVC) has been considered an important tool for supporting biowaivers, setting dissolution acceptance criteria, and more recently in the Quality by Design (QbD) framework promoting the establishment of clinically meaningful drug product specifications using dissolution as the endpoint. Based on our review experience at the FDA, for the purposes of this article, we analyzed the current state of regulatory submissions containing IVIVC approaches and discussed the successes and failures from the perspectives of study design to methodology. In the past decade, the overall acceptance rate of the IVIVC submissions is about 40%.

Interprofessional education and practice in an Indian setting.

With current global healthcare trends, there is a growing need for interprofessional education (IPE) and interprofessional practice (IPP) in collaborative care of persons with chronic medical conditions. Tools and models for IPE and IPP are now available, but they are not yet in widespread use. Developmental-behavioural paediatrics is a medical discipline that is characterized by IPP with an encouraging emergence of this speciality in India and other developing countries.

Gene expression study of phase I and II metabolizing enzymes in RPTEC/TERT1 cell line: application in in vitro nephrotoxicity prediction.

1. The phase I and II metabolizing enzymes of kidneys play an important role in the metabolism of xenobiotic as well as endogenous compounds and proximal tubules of kidney constitute high concentration of these metabolizing enzymes compared with the other parts. 2.

17-β Oestradiol prevents cardiovascular dysfunction in post-menopausal metabolic syndrome by affecting SIRT1/AMPK/H3 acetylation.

Background And Purpose: Oestrogen therapy is known to induce cardioprotection in post-menopausal metabolic syndrome (PMS). Hence, we investigated the effect of 17-β oestradiol (E2) on functional responses to angiotensin II and cardiovascular dysfunction in a rat model of PMS.

Experimental Approach: PMS was induced in ovariectomized rats by feeding a high-fat diet for 10 weeks.