Therapeutic Goods Administration Australia Preclinical Evaluation of Application for Registration
ثبت نشده
چکیده
Dose recommended is one vial of 150 MBq ( 4 mCi) per injection. "Alternatively in particularly heavy or light framed patients a dose of 2 MBq (55 !lCi)/kg 'fat-free' body weight may be used. Repeat administration should not be performed within three months of the previous METASTRON injection. Further administrations are not indicated in patients who have not responded to a previous administration of METASTRON."
منابع مشابه
Trials and tribulations in the removal of dextropropoxyphene from the Australian Register of Therapeutic Goods.
• The Therapeutic Goods Administration determined in November 2011 that dextropropoxyphene should be removed from the Australian Register of Therapeutic Goods. This is consistent with this drug's removal from the market in many other developed countries. • However, dextropropoxyphene is still on the market in Australia owing to a series of appeals made to the Administrative Appeals Tribunal (AA...
متن کاملAn overview on Ga-68 radiopharmaceuticals for positron emission tomography applications
Gallium-68 a positron emitter radionuclide, with great impact on the nuclear medicine, has been widely used in positron emission tomography (PET) diagnosis of various malignancies in humans during more recent years especially in neuroendocrine tumors (NETs). The vast number of 68Ge/68Ga related generator productions, targeting molecule design (proteins, antibody fragments,...
متن کاملThe new age of pharmacovigilance.
The Therapeutic Goods Administration is strengthening pharmacovigilance, but strategies to encourage the conduct of pharmacoepidemiological research in Australia are needed.
متن کاملRegulation of Medical Devices involving Software in Australia - an Overview
The Therapeutic Goods Administration (TGA) regulates the supply of therapeutic goods in Australia – including medical devices. Many medical devices are not programmable, electronic, or even electrical. However more devices are becoming programmable, and existing medical device software is becoming more complex. Currently in Australia, certain types of medical devices are subjected to extensive ...
متن کاملO-17: Human Ovarian Tissue Xenotransplantation Application in Drug Discover
Background: Reproductive toxicity studies (RTS) represent an important part of pre-clinical safety evaluation of any drug development process for human consumption. It is mandatory requirement that RTS must be completed before any drug can be administered to women of childbearing age. Therefore, at first segment of toxicity check the toxic effect of the drug on fertility must be tested on non-c...
متن کامل