Advanced P407/Tw80/βCD based Nasal Powders of Ropinirole Hydrochloride for Nose-to-Brain Delivery in Parkinson's Disease: Preparation and Comprehensive In Vitro and Ex Vivo Evaluation [0.03%]
用于帕金森病鼻脑递送的盐酸罗皮尼罗P407/Tw80/βCD鼻粉剂的制备及综合体外和离体评价
Elmina-Marina Saitani,Paraskevi Papakyriakopoulou,Stefanos Kikionis et al.
Elmina-Marina Saitani et al.
This study focuses on the development of lyophilized nasal powders of ropinirole hydrochloride (RH), composed of Poloxamer 407 triblock copolymer (P407), surfactant Tween 80 (Tw80) and derivatives of βCD [methyl-β-CD (MβCD) or hydroxy-pr...
Insights from a Survey of Drug Formulation Experts: Challenges and Preferences in High-Concentration Subcutaneous Biologic Drug Development [0.03%]
药物制剂专家调查见解：高浓度生物制剂皮下给药开发中的挑战及偏好的研究
Mehul Desai,Amitava Kundu,Michael Hageman et al.
Mehul Desai et al.
Increasing the concentration of intravenous (IV) biologic formulations to render them appropriate for subcutaneous (SC) delivery is challenging because it impacts many interrelated variables, including volume, viscosity, and stability. This...
Can Sex-based Variations in the Immune Responses to AAV Gene Therapy Affect Safety and Efficacy? A Review of Current Understanding [0.03%]
性别差异对AAV基因治疗免疫反应的影响及对未来研究的展望——目前的理解与思考
Leila Abdelhamid,Ronit Mazor
Leila Abdelhamid
As the field of gene therapy advances and as the importance of sex as a biological variable in shaping viral immune responses is recognized, the impact of sex on adeno-associated virus (AAV) vectors mediated gene therapies remain largely un...
Cellular Immunogenicity Assessments in CAR-T Cell Therapies: Current Insights and Future Directions [0.03%]
CAR-T细胞疗法的细胞免疫原性评估：当前见解与未来方向
Madhan Masilamani,Nanda Balasubramanian,Johanna Mora et al.
Madhan Masilamani et al.
CAR-T-cells can drive MHC class-I-mediated CD8 + cytotoxic T-cell response towards CAR constructs in addition to an antibody response. Immune response may also develop towards residuals present in the CAR-T cell product such as AAV, CRISPR/...
Pharmacokinetics of Racemic Eflornithine in Human Plasma and Cerebrospinal Fluid: Clinical Perspectives for L-eflornithine Against Human African Trypanosomiasis [0.03%]
雷南昔利在人血浆和脑脊液中的药代动力学：L-昔多福韦治疗非洲睡眠病的临床意义
Mikael Boberg,Kesara Na-Bangchang,Michael Ashton et al.
Mikael Boberg et al.
Intravenous dosing of L- and D-eflornithine in a racemic mixture is a currently recommended late-stage gambiense human African trypanosomiasis (g-HAT) treatment, either as 14-day monotherapy or in combination with oral nifurtimox for seven ...
Recent Advances in Bioanalytical Methods for Quantification and Pharmacokinetic Analyses of Antibody-Drug Conjugates [0.03%]
抗体偶联药物定量和药代动力学分析的生物分析方法的新进展
R M Naseer Khan,Yi Zeng,Abdul-Azeez A Lanihun et al.
R M Naseer Khan et al.
Antibody-drug conjugates (ADCs) represent a rapidly expanding class of therapeutics, uniquely combining the specificity of monoclonal antibodies with the potency of cytotoxic small-molecule payloads. Due to their inherent structural complex...
Commentary and Review on Prospective Prediction of Bioequivalence of Oral Dosage Forms using Compendial Dissolution Testing and PBPK Modeling [0.03%]
基于药典溶出度试验和PBPK建模的口服固体制剂生物等效性预测评述
Kazuko Sagawa,Priyanka Thipsay
Kazuko Sagawa
A virtual bioequivalence (VBE) approach utilizing physiologically based pharmacokinetic (PBPK) modeling presents a compelling alternative for pharmaceutical industries. This method can significantly reduce the time and cost associated with ...
Comparison of Branched DNA to RT-qPCR Technology for the Quantitation of mRNA from mRNA-LNP Drug Product in Human Serum [0.03%]
用于人血清中mRNA-LNP药物产品mRNA定量的 branched DNA与RT-qPCR技术比较
Carl A Luongo,Ashley D Wright,Timothy L Lochmann et al.
Carl A Luongo et al.
Accurate quantitation of circulating messenger RNA (mRNA) is critical for the quantitation of lipid nanoparticle-formulated mRNA (mRNA-LNP) drug products. This study evaluated the concordance between branched DNA (bDNA) and reverse transcri...
Clinical Trial
The AAPS journal. 2025 Sep 3;27(6):137. DOI:10.1208/s12248-025-01126-6 2025
The Impact of Using Measured In Vitro Data to Develop Physiologically Based Pharmacokinetic Models of Dermal Absorption: An IVIVE Case Study [0.03%]
基于体外数据建立生理药动模型描述经皮吸收的跨尺度模型验证案例研究
Yanling Zhang,James F Clarke,Yuri Dancik
Yanling Zhang
In vitro permeation testing (IVPT) is commonly used to assess dermal drug delivery, yet its utility can be challenged by high variability and the need for large sample sizes to achieve sufficient statistical power. Dermal physiologically ba...
Beyond Accuracy, Precision and TAE: Direct assay Validation Against Product Specification Aligned with USP [0.03%]
超越准确性、精密度和TAE：直接以USP相符合的产品质量标准进行方法学验证
Davor Josipovic
Davor Josipovic
Traditional validation methodologies - whether based on accuracy and precision or total analytical error (TAE) and risk - focus primarily on the intrinsic performance of an analytical procedure, largely disregarding its intended use environ...