PURPOSE The current methods used to evaluate the efficacy of drug products are inadequate. We propose a non-inferiority approach to prove the safety of drugs. MATERIALS AND METHODS Traditional hypotheses for the evaluation of the safety of drugs are based on proof of hazard, which have proven to be inadequate. Therefore, based on the concept of proof of safety, the non-inferiority hypothesis ...

Over the past decades, health care delivery has become more complex, and the traditional roles and relationships that structure this process have altered to allow new decision makers to enter the arena. Responsibility for drug safety, previously perceived by the public as belonging to regulatory bodies and physicians, has, in their eyes, now extended to the manufacturer. Increasingly, benefits ...

While discussions continue about the precise role of data mining in drug safety, there can be little doubt that data mining algorithms have established themselves as a component of the pharmacovigilance “tool-kit”. The drug safety community should facilitate research into the development and testing of novel data mining and statistical algorithms that match the importance and complexity of the ...

Despite advancements in genetics, chemistry, and protein engineering, recent years have seen fewer approvals of new drugs, increases in development costs, and high-profile drug withdrawals. This article focuses on technologic methods for improving drug development efficiency. These technologies include high-content cell screening, expression profiling, mass spectroscopy, mouse models of disease...

Objective: Adverse drug reactions (ADRs) are a well-known cause of hospital Abstract admission. Nevertheless a quantitative estimate of the preventability of and physicians' awareness of these reactions is lacking. Study Design and Methods: Using intensive bedside and computer-assisted drug surveillance methods a 13-month prospective pharmacoepidemiological survey was carried out on patients ad...

Approximately six years after the cyclooxygenase-2 (COX-2) inhibitors were approved for use in the United States, the results of three randomized, placebo-controlled trials provide new evidence about the cardiovascular risks of rofecoxib, celecoxib, and valdecoxib. 1-3 The Adenomatous Polyp Prevention on Vioxx (APPROVe) trial, a study of patients with a history of colorectal adenomas, was stopp...

Since their introduction in the 1960s, inhaled -agonists have been celebrated for their ability to offer dramatic relief of symptoms for persons with asthma. However, they have engendered considerable controversy. Early indications suggested that higher doses of some of the shortacting -agonists were associated with higher fatal and near-fatal asthma-related events (1). Further research suggest...

Members of the solute carrier (SLC) family of transporters are responsible for the cellular influx of a broad range of endogenous compounds and xenobiotics in multiple tissues. Many of these transporters are highly expressed in the gastrointestinal tract, liver, and kidney and are considered to be of particular importance in governing drug absorption, elimination, and cellular sensitivity of sp...

One of the important roles of pharmacists is to continue their contributions to new drug discovery and development. However, it seems to be very difficult to obtain patient satisfaction with new drugs. Because new medicines have both benefit and risk, there should be many systems to maximize the safety and efficacy of the drugs. In clinical trials, the rights, safety and welfare of human subjec...