Objective To provide suggestions for further improvement of China's drug post-approval change management system.Methods The current legal and regulatory re... X Lv,Z Huang - 亚洲社会药学(英文) 被引量: 0发表: 2023年 A Review on Drug Combination Strategy for Pharma Life Cycle Management Objective...
A system and method are provided for collecting all data relevant to a drug product throughout the life cycle of the drug product(life cycle data), applying a common rules set to determine and initiate responsive action and storing the collected data into a centralized data repository. The ...
Omidian H, Omidi Y. Blockchain in Pharmaceutical Life Cycle Management. Drug Discov Today. 2022 Feb 3:S1359-6446(22)00040-X. doi: 10.1016/j.drudis.2022.01.018. --- End ---
etc.) require a well-defined and consistent drugs and biologics development process and life cycle management. The established chemistry and manufacturing and controls (CMC) activities ensure methods are validated, raw materials are chosen and tested, and the product meets the set specifications for ...
Fabrication of existing drugs with maximal drug exposure, less toxicity, expanded intellectual property by drug life cycle management and minimized competition during the drug׳s life time can be achieved through nanoparticle-based drug delivery systems. In fact, viable formulations for poorly soluble ...
Per the ICH S5(R3) guidance, TK data from single- and repeat-dose studies is essential when assessing a drug’s risk across the life cycle.2 As such, it is an expectation that the sponsor collect samples for TK analysis during any...
Drug addiction is responsible for millions of deaths per year around the world. Still, its management as a chronic disease is shadowed by misconceptions from the general public. Indeed, drug consumers are often labelled as “weak”, “immoral” or “depraved”. Consequently, drug addiction is of...
Successful biopharmaceutical companies have coupled investment with the belief that RWE is a critical component of development and life-cycle management, and committed to this by building RWE-generation capabilities on a large scale. Providers have similarly embraced RWE to inf...
and cost-effective development of such products. FDA and EMA regulations and ICH guidelines continue to evolve to reflect the complexity of regulated products and fulfill public health goals. They play a key role in ensuring quality management ...
Test Case ManagementThe testing tools in provide many tools that help in creating and maintaining effective manual and automated test cases. Test plans in are auditable entities that contain test cases that are grouped by area, linked to a requirement, or both. This allows for complete ...