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Guidance for Industry. [23] This guidance provides sponsors and review staff with the Agency’s thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in clinical trials for human drugs, including drugs subject to licensing as biological products.
Indian Accounting Standard (abbreviated as Ind_AS) is the accounting standard adopted by companies in India and issued under the supervision of Accounting Standards Board (ASB) which was constituted as a body in the year 1977.
The Schedule 3 list is one of three lists. Chemicals which can be used as weapons, or used in their manufacture, but which have no, or almost no, legitimate applications as well are listed in Schedule 1, whilst Schedule 2 is used for chemicals which have legitimate small-scale applications. The use of Schedule 1, 2, or 3 chemicals as weapons is ...
The Food Safety and Standards Authority of India (FSSAI) is a statutory body under the administration of the Ministry of Health and Family Welfare, Government of India.It regulates the manufacture, storage, distribution, sale, and import of food articles, while also establishing standards to ensure food safety. [4]
Schedule 8 (S8) drugs and poisons, otherwise known as Controlled Drugs, are schedule 9 prohibited substances that are appropriate preparations for therapeutic use which have high potential for abuse and addiction. The possession of these medications without authority is the same as carrying a prohibited substance and is illegal.
Download as PDF; Printable version; In other projects Appearance. ... This is a documentation subpage for Template:IND. It may contain usage information, ...
Owing to the importance of the IB in maintaining the safety of human subjects in clinical trials, and as part of their guidance on good clinical practice (GCP), the U.S. Food and Drug Administration (FDA) has written regulatory codes and guidances for authoring the IB, and the International Conference on Harmonisation (ICH) has prepared a ...
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.