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With stability testing, pharmaceutical industry inspects the quality of drug substances and drug products as per the guidelines outlined by US Food and Drug Administration and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to make sure that they retained the quality over the period of time.
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.
On 24 February 1976, the treaty was signed into force by the leaders of the original members of ASEAN. [1] Other members acceded to it upon or before joining the bloc. It was amended on 15 December 1987 by a protocol to open the document for accession by states outside Southeast Asia, [2] and again on 25 July 1998, to condition such accession on the consent of all member states. [3]
The minimum essential documents that are required for the registration of pharmaceutical products designed for human use are specified in the document 'ICH Good Clinical Practices,' published in 1997 by the ICH [2] Example ICH essential documents that would be required in any US, EU or Japan based clinical trial would include: signed protocol ...
An IB is intended to provide the investigator with insights necessary for management of study conduct and study subjects throughout a clinical trial. An IB may introduce key aspects and safety measures of a clinical trial protocol, such as: Dose (of the study drug) Frequency of dosing interval; Methods of administration; Safety monitoring ...
The treaty includes a protocol under which the five nuclear-weapon states recognized by the Treaty on the Non-Proliferation of Nuclear Weapons (NPT), namely China, the United States, France, Russia and the United Kingdom (who are also the five permanent members of the United Nations Security Council) undertake to respect the Treaty and do not ...
United States: Although ICH GCP guidelines are recommended by the Food and Drug Administration (FDA), [4] they are not statutory in the United States. The National Institutes of Health requires NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be ...
The Bay of Bengal Initiative for Multi-Sectoral Technical and Economic Cooperation (BIMSTEC) is an international organisation of seven South Asian and Southeast Asian nations, housing 1.73 billion people and having a combined gross domestic product of US$5.2 trillion (2023).