The safety and efficacy of new drug approval.

نویسنده

  • D H Gieringer
چکیده

The perception that agencies are out of control arises from the fact that in being called on to make fundamental value judgments they have moved outside their accustomed sphere of activity, outside their expertise, and outside the established system of controls. This perturbation ofthe regulatory process will not be corrected until the agencies are relieved of the necessity of makingjudgments they are not equipped to make.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Study on the linezolid prescription according to the approval of indication in a University Hospital

Indications for linezolid use are nosocomial or community-acquired pneumonia and skin infections or soft tissue infection caused by gram-positive microorganisms, but new recommendations may emerge. It is important to balance benefits with risks because severe adverse events have been described in patients taking linezolid treatment. Accordingly, we evaluated the suitability of linezolid prescri...

متن کامل

Study on the linezolid prescription according to the approval of indication in a University Hospital

Indications for linezolid use are nosocomial or community-acquired pneumonia and skin infections or soft tissue infection caused by gram-positive microorganisms, but new recommendations may emerge. It is important to balance benefits with risks because severe adverse events have been described in patients taking linezolid treatment. Accordingly, we evaluated the suitability of linezolid prescri...

متن کامل

Efficacy and safety of conventional long acting β2- agonists: systematic review and meta-analysis

Background: Chronic obstructive pulmonary disease (COPD) is usually considered one of the leading causes of death worldwide, so finding proper therapeutic strategies for this disease is of high importance. In this meta-analysis, we reviewed the existing literature on the efficacy and safety of conventional long acting beta agonists (LABAs) in COPD patients. Methods: We searched MEDLINE and G...

متن کامل

New Platforms For Drug Screening And Toxicology: Necessity Or Need?

The liver is the largest internal organ in the human body that is responsible for more than 500 vital functions, including biosynthesis of major plasma proteins, immunity against infectious pathogens, balancing energy metabolism and xenobiotics biotransformation (1). One of the main functions of the liver is an important role in drug metabolism (2). Since developing new drug compounds into mark...

متن کامل

Computational tools and interdisciplinary ingenuity for accelerating the development of new medicine

The rising costs of research and development, coupled with the low probability of reaching approval, have resulted in many big pharma’s being risk adverse and less likely to pursue novel targets. Research and development to point of marketing costs have been increasing at an annual rate of 8.5% above inflation [3]. On the order of 90% of the compounds entering clinical trials do not meet the re...

متن کامل

Safety, Tolerability, and Efficacy of Acupuncture in Management of Neonatal Abstinence Syndrome (NAS): A Systematic Review

Background: The Neonatal Abstinence Syndrome (NAS) has been treated so far by various drugs, such as opioids and non-opioids. There is some concern about NAS babies who receive chemical drug treatment. Some researchers mentioned that shorter pharmacological treatment and less lengthy hospitalization are associated with severa...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:
  • The Cato journal

دوره 5 1  شماره 

صفحات  -

تاریخ انتشار 1985