Comment from Bhardwaj et al on "Comprehensive stress study on recombinant adeno-associated virus vectors: Evaluating the capabilities of established analytical techniques" [0.03%]
巴尔德瓦吉等人对“重组腺相关病毒载体的全面应力研究：评估 Established Analytical Techniques 分析技术的能力”的评论
Abhay Bhardwaj,Daksh Bhatia,Anuj Pathak et al.
Abhay Bhardwaj et al.
Reply to comments on "Comprehensive stress study on recombinant adeno-associated virus vectors: Evaluating the capabilities of established analytical techniques" [0.03%]
关于“重组腺相关病毒载体的全面应力研究：评估 established 分析技术的能力”的评论回复
Jakob Heckel,Lukas Bongers,David Naylor et al.
Jakob Heckel et al.
Development of a SMEDDS for oral delivery of hydrophilic peptide difelikefalin acetate: Preparation, characterization, and PK/PD evaluation [0.03%]
一种用于口服给药的亲水性肽difelikefalin乙酸盐的SMEDDS制剂的研发：制备，表征及PK/PD评价
Congmei Ming,Zhongyuan Li,Wu Zhou
Congmei Ming
Difelikefalin acetate (DF) is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients undergoing hemodialysis. The marketed formulation is an injectable, while this study aims to d...
Comment from Ailani et al on "Comprehensive stress study on recombinant adeno-associated virus vectors: Evaluating the capabilities of established analytical techniques" [0.03%]
Ailani等对“重组腺相关病毒载体的全面应力研究：评估 Established Analytical Techniques 的能力”的评论
Tanmay Ailani,Reenoo Jauhari,Anjna Rani et al.
Tanmay Ailani et al.
A machine learning approach to identify active polysorbate 20 degrading hydrolases in biopharmaceutical formulations [0.03%]
基于机器学习的多索他韦II型降解酶筛选及作用机制研究
Melanie Maier,Simon Kluters,Joey Studts et al.
Melanie Maier et al.
Polysorbate degradation by host cell-derived hydrolases presents a critical challenge in biopharmaceutical formulations. It can lead to fatty acid release, particle formation and reduced product stability. Mass spectrometry-based host cell ...
Impact of pneumatic tube system transportation on product quality of therapeutic monoclonal antibody lyophilized and reconstituted drug products [0.03%]
气动传输系统对治疗性单克隆抗体冻干粉及复溶药液产品品质的影响研究
Kashappa Goud Desai,Cait Sofa,James D Colandene et al.
Kashappa Goud Desai et al.
Pneumatic tube systems (PTSs) provide an efficient means of rapidly transporting samples within hospitals. The feasibility of using hospital PTSs to transport therapeutic monoclonal antibody (mAb) dosing solutions in intravenous infusion co...
Role of saturation dynamics in driving skin permeation from topical gel formulations [0.03%]
饱和动力学在皮肤凝胶制剂经皮渗透中的作用研究
Srinath Rangappa,Srinivasa Ajjarapu,Vijay Kumar Shankar et al.
Srinath Rangappa et al.
The thermodynamic activity of an active pharmaceutical ingredient (API) is a key driver of permeation performance in topical formulations. This study investigated how solvent composition and evaporation impact the degree of saturation (DS) ...
A unified physiologically based pharmacokinetic model for low-to-high oral, subcutaneous, and intravenous dose of methotrexate in humans [0.03%]
人用甲氨蝶呤低至高口服、皮下和静脉给药的统一生理基于药代动力学模型
Min-Soo Kim,Shirley Wang,Paola Mian et al.
Min-Soo Kim et al.
Methotrexate (MTX) is used to treat both inflammatory conditions and cancers, administered in a wide range of oral, subcutaneous and intravenous doses. MTX's nonlinearities are well recognized in both absorption and disposition. However, no...
Therapeutic monoclonal antibodies in the central nervous system: Pharmacokinetics, bioanalysis and clinical implications [0.03%]
中枢神经系统的治疗单克隆抗体：药代动力学，生物分析及临床意义
Isaac G Onyango,Naruewan Woolf,Joseph Green et al.
Isaac G Onyango et al.
Therapeutic monoclonal antibodies (mAbs) hold major promise as precision diagnostics and disease-modifying agents for central nervous system (CNS) disorders, yet their translation is constrained by limited permeability across the blood brai...
Fernando Alvarez-Nunez,Hwee Jing Ong,Samuel H Yalkowsky
Fernando Alvarez-Nunez
The general solubility equation (GSE) is widely used in the pharmaceutical and environmental sciences to estimate the aqueous solubility of molecules that are nonionizable in the pH range of 2-13 from their melting point and octanol-water p...