Integrated drug prod- uct development--from lead candidate selection to life-cycle management. The Process of New Drug Discovery and Develop- ment. 2006:15.Pudipeddi, M., Serajuddin, A. T. M., Mufson, D., In- tegrated Drug Product Development - From Lead Candidate Selection to Life-...
product life cycle managementvirtual engineeringweb-based servicesGlobalization has created a situation of increased international competition, which has put ... A Molina,J Aca,P Wright - 《International Journal of Computer Integrated Manufacturing》 被引量: 66发表: 2005年 Design of product modularity ...
专利名称：Drug life cycle management system 发明人：Ramon J. Dempers 申请号：US11652849 申请日：20070111 公开号：US20070185751A1 公开日：20070809 专利内容由知识产权出版社提供 专利附图：摘要：A system and method are provided for collecting all data relevant to a drug product throughout the life ...
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 ...
product may involve multiple parties from different countries, there are chances for the product to be improperly formulated or packaged, contaminated, diverted, counterfeited, or adulterated. Thus, compliance and surveillance activities overseen by...
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 ...
IPD Analytics offers industry leading life-cycle analysis, clinical and formulary insights, brand and generic market impact forecasts, and coding and reimbursement information
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management. RLD :Yes TE Code : FENOFIBRIC ACID Brand Name :FIBRICOR Dosage Form :TABLET;ORAL Dosage Strength :105MG Approval Date :2009-08-14 Application Number :22418 ...
•Risk management activities over the life cycle of a product •An effective pharmaceutical quality system This guidance applies to CPs submitted in NDAs, ANDAs, BLAs, and supplements to these applications regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologi...
Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, as well as: Guidance for pharmaceutical professionals to qualify and risk-assess container closure system leachables and extractables in drug products ...