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Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. The word formulation is often used in a way that includes dosage form .
The CTD is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
Part 1 of the manual approaches the process of research and writing. This includes providing "practical advice" to formulate "the right questions, read critically, and build arguments" as well as helping authors draft and revise a paper. [3] Initially added with the seventh edition of the manual, this part is adapted from The Craft of Research ...
Geoscience Reporting Guidelines—for geoscience reports in industry, academia and other disciplines. [30] Handbook of Technical Writing, by Gerald J. Alred, Charles T. Brusaw, and Walter E. Oliu.—for general technical writing. IEEE style—used in many technical research papers, especially those relating to computer science.
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
In medicine, a clinical study report (CSR) on a clinical trial is a document, typically very long, providing much detail about the methods and results of a trial. A CSR is a scientific document addressing efficacy and safety, not a sales or marketing tool; its content is similar to that of a peer-reviewed academic paper. [1]
Medical writing for the pharmaceutical industry can be classified as either regulatory medical writing or educational medical writing. [citation needed]Regulatory medical writing means creating the documentation that regulatory agencies require in the approval process for drugs, devices and biologics.
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies.Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, [1] cosmetics, [2] pharmaceutical products, [3] dietary supplements, [4] and medical devices. [5]