Nonclinical pharmacodynamic studies in t
β
Ronald D. Smith
π
Article
π
1994
π
John Wiley and Sons
π
English
β 214 KB
Every new drug application (NDA or international equivalent) contains general pliarinacology, ancillary pharmacology, or safety phurmacology studies. Until recently, these studies have been carricd out at the discretion of the new drug sponsor and the individual regulatory agency. Two recent events