Search
Search Results
-
Changes in regulators of lipid metabolism in the brain: a study of animal models of depression and hypothyroidism
Metabolic disturbances in the brain are assumed to be early changes involved in the pathogenesis of depression, and these alterations may be...
-
Adoption of Decentralization: Are Our Perceptions Holding Us Back?
Incorporating decentralized approaches into clinical trials is a critical innovation with potential implications for improved accessibility and...
-
Simultaneous Global Drug Development and Multiregional Clinical Trials (MRCT): 5 Years After Implementation of ICH E17 Guidelines
The ICH E17 guidelines (2014–2017) on Multiregional Clinical Trials (MRCT) was a joint effort by the regulators and industry to facilitate...
-
The Impact of Serialisation on Operational Efficiency and Productivity in Irish Pharmaceutical Sites
Technology enabling drug serialisation technology was introduced by regulators to enhance security in pharmaceutical supply chain and protect drugs...
-
Features of Planning and Conducting Bioequivalence Studies with an Adaptive Design for Drug Analogs of Endogenous Compounds
There is a constant interest in the study of drugs that are analogs of endogenous compounds. Guidelines for conducting bioequivalence studies are...
-
Use of Real-World Evidence for Drug Regulatory Decisions in China: Current Status and Future Directions
Real-world data (RWD) and real-world evidence (RWE) have garnered great interest for supporting drug research and development (R&D) by medical...
-
Regulatory Pathways Supporting Expedited Drug Development and Approval in ICH Member Countries
Regulators and pharmaceutical companies across the world are intensifying efforts to get increasingly complex and innovative drugs to patients with...
-
Evidence on Real-World Data and Real-World Evidence as a Driver for Precision Medicine Implementation in Pharmacy Practice
Today, pharmacy and pharmaceutical professionals, including pharmacy students and trainees, are highly encouraged to explore, contemplate, and...
-
Leveraging Patient Preference Information in Medical Device Clinical Trial Design
Use of robust, quantitative tools to measure patient perspectives within product development and regulatory review processes offers the opportunity...
-
Dysregulation of histone deacetylases in ocular diseases
Ocular diseases are a growing global concern and have a significant impact on the quality of life. Cataracts, glaucoma, age-related macular...
-
All-round approaches to increase adverse drug reaction reports: a sco** review
IntroductionMedicines are among the most effective technologies for reducing mortality and morbidity. Adverse drug reactions (ADRs) are a...
-
Access to Innovative Medicines: Regulation Change and Factors Associated with Drug Approval Lag in Malaysia
BackgroundDrug approval lag is the time difference for new medicine to obtain marketing authorization approval in the study country compared to the...
-
Neuroendocrine microRNAs linked to energy homeostasis: future therapeutic potential
The brain orchestrates whole-body metabolism through an intricate system involving interneuronal crosstalk and communication. Specifically, a key...
-
Decentralized Clinical Trials: Scientific Considerations Through the Lens of the Estimand Framework
While industry and regulators’ interest in decentralized clinical trials (DCTs) is long-standing, the Covid-19 pandemic accelerated and broadened the...
-
Risk Management in Drug-Device Combination Product Development
Breakthrough innovations in drug and biologic based therapies as well as technological developments in design and development of medical devices have...
-
Using Administrative Data from Public Health and Drug Programs
This entry presents an overview of how real-world administrative data, routinely available as part of clinical practice within healthcare systems,...
-
Diversity Plans and Postmarketing Studies: First Impressions of Anticipated Diversity Requirements in the United States
IntroductionRecent Food and Drug Administration (FDA) draft guidelines are intended to improve representation and formalize the assessment of race...
-
Direct-to-Consumer Genetic Testing: A Comprehensive Review
Emerged in the early 2000s, direct-to-consumer (DTC) genetic testing has helped consumers access and understand their genetic information without the...
-
Bayesian Strategies in Rare Diseases
Bayesian strategies for planning and analyzing clinical trials have become a viable choice, especially in rare diseases where drug development faces...
-
Treatment and disposal practices of pharmaceutical effluent containing potential antibiotic residues in two states in India and perceptions of various stakeholders on contribution of pharmaceutical effluent to antimicrobial resistance: a qualitative study
BackgroundAntimicrobial resistance (AMR) is a looming pandemic, demanding prompt actions to avert catastrophic consequences. Effluents from...