Anticancer drug development Guide
Abstract: Every new anti-cancer drug or drug combination is evaluated for safety and efficacy before being approved. Clinical development of cytotoxic anticancer drugs classically follows three main phases. Phase I trials represent the first administration of a new drug or combination to human beings. Their primary goal is to determine the recommended phase two dose and also to collect toxicity, pharmacokinetic and pharmacodynamic data. Phase II trials are screening studies aimed at identifying signals of anti-tumor activity in a specific tumor type and setting. Phase III trials aim to compare the efficacy of a new treatment with standard of care and can lead to regulatory approval when positive. The recent emergence of molecularly targeted agents has challenged the traditional developmental pathway for anti-cancer drugs. Using biomarker enriched patient populations has been successful for a few agents. Otherwise, new types of trials have been proposed for these agents in an attempt to elucidate their mechanism of action, such as phase 0 trials and "window of opportunity" trials. These two types of trials and the classical three phase trials are discussed in detail.
According to the Pharmaceutical Research and Manufacturers of America, there are more than 800 anti-cancer agents that are currently in active clinical development ( This number represents a 143% rise in the number of oncology drugs being developed in the last decade alone. The increased rate of new anti-cancer therapy investigations can be attributed at least, in part, to improved comprehension of cancer biology mechanisms. As opposed to cytotoxic agents that target DNA, tubulin, or cell division machinery, novel agents have recently emerged that selectively target molecular pathways thought to be critical for tumor survival, growth, and metastases.
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FDA in industry's pocketby Tek_Jansen
That regulatory agency has been "captured". They know about the problem
but somehow can't say no to the meat industry.
The EU and UK regulators aren't so weak:
A key concern is that the development of bugs that laugh at vancomycin (a last line of defense against bacteria that resist all other antibiotics) could lead to a "doomsday scenario" with bacterial epidemics reminiscent of the Dark Ages. In 1997, the European Union banned avoparcin, a drug related to vancomycin, from animal feed after studies linked it to the development of vancomycin-resistant bacteria
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