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http://dx.doi.org/10.1016/S1473-3099(12)70080-4 | DOI Listing |
Bioanalysis
September 2025
GSK, Precision Medicine Design Assurance, Stevenage, UK.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use M10 guideline provides a global framework for bioanalytical method validation in studies intended for regulatory submission. While its structure ensures consistency and data reliability, the guideline also acknowledges that not all studies require the same level of validation. This paper examines where full compliance is essential and where scientific judgment allows for leaner, context-driven validation, such as in early-stage development, for additional matrices, metabolites, nonstandard biological matrices or studies intended for internal decision-making.
View Article and Find Full Text PDFNan Fang Yi Ke Da Xue Xue Bao
August 2025
Guangzhou Twelfth People's Hospital, Guangzhou 510700, China.
Objectives: To explore the efficacy of DSA-guided intrathecal drug delivery system combined with Acupoint Therapy for management of cancer pain and provide reference for its standardized clinical application. Methods and.
Results: Recommendations were formulated based on literature review and expert group discussion, and consensus was reached following expert consultation.
Nan Fang Yi Ke Da Xue Xue Bao
August 2025
Institute of Biomedical and Health Engineering, Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, Shenzhen 518055, China.
Objectives: To synthesize a temperature-responsive multimodal motion microrobot (MMMR) using temperature and magnetic field-assisted microfluidic droplet technology to achieve targeted drug delivery and controlled drug release.
Methods: Microfluidic droplet technology was utilized to synthesize the MMMR by mixing gelatin with magnetic microparticles. The microrobot possessed a magnetic anisotropy structure to allow its navigation and targeted drug release by controlling the temperature field and magnetic field.
Curr Drug Saf
September 2025
Department of Pharmaceutics, Jayawantrao Sawant College of Pharmacy and Research, Savitribai Phule Pune University, Pune, 411028, India.
The drug approval and review process plays a crucial role in the pharmaceutical industry, aiming to ensure that newly marketed drugs are safe, effective, and of high quality. Regulatory authorities overseeing this process, tailored to geographically distinct needs, include the U.S.
View Article and Find Full Text PDFMagn Reson Chem
September 2025
Jiangsu Institute for Food and Drug Control (JSIFDC), Nanjing, Jiangsu, China.
The research team established a quantitative H NMR method to determine the relative ethoxy content (EO%) in ethylcellulose using a CDCl/TFA-d solvent mixture. High-field NMR spectroscopy enabled direct measurement without the use of internal or external calibrants by integrating the methyl proton signals (δ 1.15 ppm) and the methylene/methine proton signals (δ 2.
View Article and Find Full Text PDF