Quality Systems

May 08, 2017
Pharmaceutical Technology
The Identification of Medicinal Products (IDMP) standards requires regulatory teams to efficiently collate data from multiple sources and functions.
May 08, 2017
Pharmaceutical Technology
Many pharmaceutical companies are sceptical about IDMP despite the business benefits and its contribution to patient safety.
May 05, 2017
By Pharmaceutical Technology Editors
The agency sent a warning letter to Sal Pharma for not disclosing information about API manufacturers to customers.
May 05, 2017
By Pharmaceutical Technology Editors
EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.
May 05, 2017
By Pharmaceutical Technology Editors
CPhI expert, Girish Malhotra believes drug costs could be lower if approval timeframes can be cut from 10 to three months.
May 02, 2017
Pharmaceutical Technology
In this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
May 02, 2017
Pharmaceutical Technology
Solid-phase extraction has several advantages over liquid/liquid extraction for extractables and leachables studies.
May 02, 2017
Pharmaceutical Technology
The author discusses the impact of prefilled syringe product contact materials and the filling and stoppering process on protein aggregates.
May 02, 2017
Pharmaceutical Technology
Value-based medicine is putting patients at the center of pharmaceutical R&D and forcing the industry to move from treatment to prevention.
May 02, 2017
Pharmaceutical Technology
Under US regulations, such as the Medicare Access and CHP Reauthorization Act of 2015 (MACRA), part of any US physician’s reimbursement will be based on patient outcomes.
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