Practice of Regulatory Science (Drug Development)
The practice of regulatory science (RS) for drug development is described. In the course material for education in pharmaceutical sciences drafted by the RS Division of the Pharmaceutical Society of Japan, RS for pharmaceuticals is defined as the science of predicting, assessing, and judging the quality, efficacy, and safety of pharmaceutical products ...
openaire +3 more sources
Implementing NMC standards for learning, and assessing in practice(2006): a demonstration of effective partnership between a higher education institution and NHS Trust placement partners [PDF]
This paper provides an account of the collaborative approach taken to implement professional standards in teaching, learning and assessing in practice for nursing and midwifery.
Agnew, Sue +4 more
core
We identified a systemic, progressive loss of protein S‐glutathionylation—detected by nonreducing western blotting—alongside dysregulation of glutathione‐cycle enzymes in both neuronal and peripheral tissues of Taiwanese SMA mice. These alterations were partially rescued by SMN antisense oligonucleotide therapy, revealing persistent redox imbalance as ...
Sofia Vrettou, Brunhilde Wirth
wiley +1 more source
In this study, we found that human cervical‐derived adipocytes maintain intracellular iron level by regulating the expression of iron transport‐related proteins during adrenergic stimulation. Melanotransferrin is predicted to interact with transferrin receptor 1 based on in silico analysis.
Rahaf Alrifai +9 more
wiley +1 more source
Clinical implications of dual therapy of acarbose plus myo-inositol on the thyroid profile in women with polycystic ovary syndrome [PDF]
Context: Polycystic ovary syndrome (PCOS) and thyroid are the most common endocrine disorders affecting women of childbearing age, causing anovulation and infertility.
Marina Andavar +3 more
doaj +1 more source
Tau acetylation at K331 has limited impact on tau pathology in vivo
We mapped tau post‐translational modifications in humanized MAPT knock‐in mice and in amyloid‐bearing double knock‐in mice. Acetylation within the repeat domain, particularly around K331, showed modest increases under amyloid pathology. To test functional relevance, we generated MAPTK331Q knock‐in mice.
Shoko Hashimoto +3 more
wiley +1 more source
The other GMP: good manufacturing practice and its importance in the validation of constructed pharmaceutical facilities [PDF]
The work reported is part of an ongoing PhD study prompted by the particular difficulties encountered when two very different quality cultures interact (in this case Pharmaceutical industry clients and Construction industry providers).
Edge, Jerry +2 more
core
Setting Standards for Fair Information Practice in the U.S. Private Sector [PDF]
The confluence of plans for an Information Superhighway, actual industry self-regulatory practices, and international pressure dictate renewed consideration of standard setting for fair information practices in the U.S. private sector.
Li, G, Yu, Y
core +3 more sources
Gut microbiome and aging—A dynamic interplay of microbes, metabolites, and the immune system
Age‐dependent shifts in microbial communities engender shifts in microbial metabolite profiles. These in turn drive shifts in barrier surface permeability of the gut and brain and induce immune activation. When paired with preexisting age‐related chronic inflammation this increases the risk of neuroinflammation and neurodegenerative diseases.
Aaron Mehl, Eran Blacher
wiley +1 more source
Regulatory systems, institutions and practices
Regulation is a fact of life. It affects the food we eat, the safety of our workplace, the goods and services we buy and sell and the quality of our natural environment. It plays an important role in guarding New Zealanders from harm, protecting our rights, and ensuring that markets work fairly and efficiently.
Steven Bailey, Judy Kavanagh
openaire +2 more sources

