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The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. [1] [2] The initial members comprised the 10 member countries of EFTA at that time.
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...
The TIFF (Tag Image File Format) format is a flexible format usually using either the TIFF or TIF filename extension. The tag structure was designed to be easily extendible, and many vendors have introduced proprietary special-purpose tags – with the result that no one reader handles every flavor of TIFF file.
This listing is limited to those independent companies and subsidiaries notable enough to have their own articles in Wikipedia. Both going concerns and defunct firms are included, as well as firms that were part of the pharmaceutical industry at some time in their existence, provided they were engaged in the production of human (as opposed to veterinary) therapeutics.
Custom in-house solutions were developed by a few individual laboratories, while some enterprising entities sought to develop commercial reporting solutions in the form of special instrument-based systems. [1] In 1982 the first generation of LIMS was introduced in the form of a centralized minicomputer, which offered automated reporting tools.
BTG Limited is an international specialist healthcare company that is developing and commercialising products targeting critical care, cancer and other disorders. The current name was adopted when the British Technology Group changed its name on 27 May 1998. [2]
An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. [1] EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices.
With this framework – according to Hinz [2] – the FDA tries to motivate the pharmaceutical industry to improve the production process. Because of the tight regulatory requirements and the long development time for a new drug, the production technology is "frozen" at the time of conducting phase-2 clinical trials.