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scFv: single-chain variable fragment. di-scFv: dimeric single-chain variable fragment. sdAb: single-domain antibody. BsAb: bispecific monoclonal antibody: 3funct: trifunctional antibody. BiTE: bi-specific T-cell engager. This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been ...
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
Adalimumab, sold under the brand name Humira and others, is a disease-modifying antirheumatic drug and monoclonal antibody used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.
Schedule 9 (S9) drugs and poisons are substances and preparations that, by law, may only be used for research purposes. The sale, distribution, use, and manufacture of such substances without a permit is strictly prohibited by law. Permits for research uses on humans must be approved by a recognised ethics committee on human research. Examples ...
The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. [4] As part of the Department of Health and Aged Care, the TGA regulates the safety, quality, efficacy and advertising in Australia of therapeutic goods (which comprise medicines, medical devices, biologicals and certain other therapeutic goods).
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
Sorafenib, sold under the brand name Nexavar, [3] is a kinase inhibitor drug approved for the treatment of primary kidney cancer (advanced renal cell carcinoma), advanced primary liver cancer (hepatocellular carcinoma), FLT3-ITD positive AML and radioactive iodine resistant advanced thyroid carcinoma.
An Australian Approved Name (AAN) is a generic drug name set by the Therapeutic Goods Administration (TGA) for use in Australia. [1] In late 2016, the TGA changed several drug names to the corresponding international nonproprietary name (INN), or, in cases where an INN was not available (as with asparaginase), another established generic name, such as the United States Adopted Name (USAN).