An Industry Perspective on Key Considerations for the ICH S13 Guidance: Nonclinical Safety Evaluations of Oligonucleotide-Based Therapeutics [0.03%]
ICH S13 指南中寡核苷酸药物非临床安全性评价的关键考虑因素之行业观点
Jennifer D Sisler,Patrik Andersson,Alan Brown et al.
Jennifer D Sisler et al.
Oligonucleotide therapeutics (ONTs) are a growing class of nucleic acid-based therapies with the potential to treat a variety of diseases through several different mechanisms of action (MoA). The most prevalent MoA entails the inhibition of...
Preclinical Safety Evaluation of BB106, a Novel Ketamine-Sulfobutylether-Beta-Cyclodextrin Salt, Following Subcutaneous Administration in Rats and Göttingen Minipigs [0.03%]
新型盐酸氯胺酮-sbe-β-cyclodextrin盐（BB106）皮下给药的大鼠和Gottingen小型猪的药物非临床安全性评价
Yuval Ramot,Isabella Andreini,Giuseppe Sacco et al.
Yuval Ramot et al.
BackgroundConventional ketamine hydrochloride solutions are acidic and hyperosmotic, limiting their tolerability for subcutaneous (SC) delivery. BB106 is a novel ketamine formulation using the multitude of sulfobutylether-beta-cyclodextrin ...
Subchronic Toxicity and Teratogenicity Studies of Mycoprotein From Fusarium compactum MM-135 in Rats [0.03%]
发酵短梗霉MM-135肌苷子的亚慢性毒性和致畸试验
Yibo Xian,Junli Liu,Luqin Yin et al.
Yibo Xian et al.
Traditional food production systems are constrained by limited arable land, climate change, and environmental pressures, necessitating the exploration of alternative protein sources. Mycoprotein from Fusarium compactum (F. compactum) MM-135...
In Vitro and In Vivo Investigational Safety Evaluation of the Probiotic Bacillus subtilis BSP110 (MTCC 25471) [0.03%]
枯草芽孢杆菌BSP110（保藏号MTCC 25471）体内外安全性研究
Sohel S Shaikh,Snehal Patel,Parin Patel et al.
Sohel S Shaikh et al.
Probiotics are living microorganisms that, when given in sufficient quantities, boost the host's health. Probiotics have been used more often in recent years as dietary supplement to prevent illnesses, including diarrhea, obesity, and const...
Challenges and Opportunities of Cosmeceutical Regulations: A Global Perspective [0.03%]
从全球视角看化妆品监管的挑战与机遇
Munish Thakur,Rajni Bala
Munish Thakur
The international cosmeceutical sector has experienced unprecedented expansion, compelling regulatory bodies to enhance and update systems to tackle consumer protection, product effectiveness, and ethical issues. This review critically eval...
Assessing the Neurotoxicity of Bisphenol A Using Network Toxicology, Molecular Docking, and Molecular Dynamics Simulation [0.03%]
基于网络毒理学、分子对接和分子动力学模拟评估双酚A的神经毒性
Wanyu Huang,Xuanyu Lin,Shuang Li et al.
Wanyu Huang et al.
Bisphenol A (BPA) is a prevalent environmental endocrine disruptor with potential impacts to the neurological system in humans. This study used an integrated method combining network toxicology, molecular docking, and molecular dynamics sim...
Pathology as a Core Discipline in the Biological Evaluation of Medical Devices [0.03%]
医疗器械生物学评价中的病理学核心学科地位
Kathleen A Funk,JoAnn C L Schuh,Brad Bolon et al.
Kathleen A Funk et al.
The device development process encompasses an intersection of biological, physical, and engineering sciences principles culminating in translation of data from nonclinical animal studies to predict potential tissue responses in human patien...
Translational Challenges From Nonclinical to Clinical Program: Case Study Examples [0.03%]
从非临床到临床项目转化的挑战：案例研究示例
Deven Dandekar,David B Hawver,Deepa B Rao et al.
Deven Dandekar et al.
Drug discovery and development is a complex, lengthy, and expensive process that takes on average 10-15 years and approximately $1-2 billion USD for approval of a new drug. While the studies needed to support clinical development are genera...
Safety Assessment of Saccharum officinarum (Sugarcane)-Derived Ingredients as Used in Cosmetics [0.03%]
药用甘蔗(Saccharum officinarum L.)衍生成分作为化妆品原料的安全性评估
Priya Ferguson,Wilma F Bergfeld,Donald V Belsito et al.
Priya Ferguson et al.
The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 4 Saccharum officinarum (sugarcane)-derived ingredients. These ingredients are mostly reported to function in cosmetics as skin-conditioning agents. Industry sho...