Search
Search Results
-
Use of Real-World Evidence in Regulatory Decisions for Traditional Chinese Medicine: Current Status and Future Directions
Traditional Chinese medicine (TCM) is a valuable resource unique to China with a long history of human use and clinical practice, which can be...
-
Cell cycle arrest-mediated cell death by morin in MDA-MB-231 triple-negative breast cancer cells
BackgroundMorin, a flavonoid extracted from Moraceace family and exhibits several pharmacological activities including anti-cancer activity . ...
-
From Print to Screen: Regulatory Considerations to Adopting Innovative Approaches for Patient Information and Safety
Patient information leaflets (PILs) differ across regulatory jurisdictions—its form and structure are dependent on the regulations it conforms to....
-
Quantitative Benefit–Risk Assessment: State of the Practice Within Industry
BackgroundBenefit–risk assessments for medicinal products and devices have advanced significantly over the past decade. The purpose of this study was...
-
Regulatory Reform Outcomes and Accelerated Regulatory Pathways for New Prescription Medicines in Australia
National Regulatory Authorities (NRAs) globally are facing the challenge of evaluating pharmaceutical products in a speedy manner, whilst...
-
Survey Result for E-labeling Initiatives in Asia
Under the COVID-19 pandemic, various electronic labeling initiatives have accelerated worldwide in the healthcare and pharmaceutical fields as part...
-
Regulatory enforcement of the marketing of fixed-dose combinations in India: a case study of systemic antibiotics
BackgroundIn India, states have licensed the manufacture of large numbers of fixed-dose combination (FDC) drugs without the required prior approval...
-
PLANT BIOTECHNOLOGY
Extensive research is underway worldwide on the production of active plant components from medicinal plants under controlled, reproducible conditions...
-
Patient and Public Perceptions in Canada About Decentralized and Hybrid Clinical Trials: “It’s About Time we Bring Trials to People”
BackgroundLittle is known about patient and the public perspectives on decentralized and hybrid clinical trials in Canada.
MethodsWe conducted an...
-
Evaluation of a Pilot: Inspection Facilitation and Collaboration Using a Mixed Reality Device
The COVID-19 pandemic forced industry and national regulatory authorities (NRAs) to think about innovative ways to ensure business continuity,...
-
Don’t Rely on Your Prescription
Most likely it’s not working for you. When you are prescribed a medicine and take it, you do so in the hope that you will have a benefit from it. Why...
-
Influence of growth regulators on distribution of trichomes and the production of volatiles in micropropagated plants of Plectranthus ornatus
The profile of volatile organic compounds, the glandular and non-glandular trichomes of Plectranthus ornatus , obtained by in vitro cultivation, was...
-
Bridging the Gap: A Comparative Investigation of Pharmaceutical Excipient Regulations
Since the awareness of adverse effects associated with pharmaceutical excipients in drug formulations, these excipients are no longer considered...
-
On Innovation
Innovation has become an increasingly common topic in healthcare. Private companies, developers, payers, and regulators are devoting attention toward...
-
Hypericin-Mediated Regulation of miR21 and miR34a and Their Target Genes in MCF7 Breast Cancer Cells
Hypericin is a polyphenolic compound derived from Hypericum perforatum L., Hypericaceae, that exhibits cytotoxic activity in various cancer cell...
-
Using Bayesian Dynamic Borrowing to Maximize the Use of Existing Data: A Case-Study
Bayesian Dynamic Borrowing (BDB) designs are being increasingly used in clinical drug development. These methods offer a mathematically rigorous and...
-
Plant Cell Suspension Culture: Modern Approaches and Problems in Drug Production (Review)
The review is focused on the current status of plant cell cultivation, prospects for the development of approaches in this field, and the formulation...
-
Oxytocin quality: evidence to support updated global recommendations on oxytocin for postpartum hemorrhage
BackgroundThe use of quality injectable oxytocin effectively prevents and treats postpartum hemorrhage, the leading cause of maternal death...
-
Targeting Endothelial Progenitor Cells Reparative Potential Via Canonical Wnt/NOX-4 Signaling Pathway in Rats Dyslipidemia: Role of Resveratrol
Signaling pathways guiding the reparative function of endothelial progenitor cells (EPCs) are complex. Conflicts involve the double-face role of...
-
Quality Management System in Production of Reference Materials
The article touches the most relevant aspects of the role of quality management systems (QMSs) in the creation and replenishment of universal bases...