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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 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 ...
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.
Pharmaceutical policy is a branch of health policy that deals with the development, provision and use of medications within a health care system. It embraces drugs (both brand name and generic), biologics (products derived from living sources, as opposed to chemical compositions), vaccines and natural health products .
Galenic formulation is named after Claudius Galen, a 2nd Century AD Greek physician, who codified the preparation of drugs using multiple ingredients. Today, galenic formulation is part of pharmaceutical formulation. The pharmaceutical formulation of a medicine affects the pharmacokinetics, pharmacodynamics and safety profile of a drug.
It requires the FDA to establish an Office of the Chief Scientist to: (1) oversee, coordinate, and ensure quality and regulatory focus of FDA intramural research programs; (2) track and coordinate intramural research awards made by each FDA center or science-based office; (3) develop and advocate for a budget to support intramural research; (4 ...
The term dosage form may also sometimes refer only to the pharmaceutical formulation of a drug product's constituent substances, without considering its final configuration as a consumable product (e.g., capsule, patch, etc.). Due to the somewhat ambiguous nature and overlap of these terms within the pharmaceutical industry, caution is ...
A series of unsuccessful and ineffective clinical trials in the past were the main reason for the creation of ICH and GCP guidelines in the US and Europe. These discussions ultimately led to the development of certain regulations and guidelines, which evolved into the code of practice for international consistency of quality research.