新办企业第一月的财务会计必须要做的工作.ppt

* * FDA Anesthetic Life Support Drugs Advisory Committee Sept. 10, 2003 Art Van Zee,MD St. Charles Clinic St. Charles, Va. 会计之家 / 会计之家 / Susstained-release hydromorphone (Palladone) --Risks vs. benefits discussion Benefits Review sustained release opioids vs. IR opioids IR oxycodone vs CR oxycodone Comparable Efficacy Safety Hale Clin J Pain 9/99 BACK PAIN Kaplan R J Clin Oncol 10/98 CANCER Stambauugh J.Clin Pharm 5/01 CANCER OxyContin--NDA--1995 MEDICAL OFFICER REVIEW (MOR) Summary of Safety “ The best conclusion is that the efficacy of the CR (oxycodone) is equivalent to the IR, with an adverse event profile that is as good as the IR. I would not allow a ‘better’ claim” --Curtis Wright, MRO OxyContin---NDA---1995 Summary of Efficacy “CR oxycodone appears to be a BID alternative to conventional QID oxycodone. Approval is recommended. Care should be taken to limit competitive promotion. This product has been shown to be as good as current therapy, but has not been shown to have a significant advantage beyond reduction in frequency of dosing.” --Curtis Wright, MRO The Medical Letter—9/17/01 “OxyContin is a q12h controlled-release formulation of oxycodone that can be used effectively in the treatment of pain due to cancer, and occasionally, other types of chronic pain. There is no evidence that oxycodone offers any advantage over appropriate doses of other opioids, and it appears to have the same potential for addiction as morphine.” CR morphine vs CR oxycodone Comparable in Efficacy and Safety Heiskanen Pain 10/97 CANCER Mucci-LoRusso ’98 CANCER Bruera J. Clin Oncol 10/98 CANCER IR hydromorphone vs CR hydromorphone (Q12hr) Comparable Efficacy and Safety Hayes Cancer 9/94 CANCER Bruera J. Clin Oncol 5/96 CANCER CR oxycodone vs CR hydromorphone (Q12hrs) Comparable Effi