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REVIEW Dose Escalation Methods in Phase I Cancer Clinical Trials Christophe Le Tourney, J. Jack Lee, Lillian L. Six Phase I clinical trials are an essential step in the development of anticancer drugs.
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Dose escalation methods in refer to the strategies or techniques used to increase the dosage of a drug incrementally to determine the optimal dosage for maximum efficacy and minimum side effects.
Typically, researchers, clinical trial sponsors, or pharmaceutical companies conducting clinical trials involving drug dosages are required to file dose escalation methods.
To fill out dose escalation methods, one needs to provide detailed information about the drug being tested, the dosage levels, the planned increments, the study objectives, and the criteria for dose escalation or de-escalation.
The purpose of dose escalation methods is to establish the safe and effective dosage of a drug, ensuring that it achieves the desired therapeutic effect while minimizing adverse effects.
The dose escalation methods report should include information such as the drug name, dosing regimen, route of administration, patient population, criteria for dose escalation or de-escalation, safety monitoring procedures, and any relevant study endpoints.
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