Following initial safety (Phase I) testing, a drug is tested for efficacy, typically in blind, randomized trials, in which a control group receives a placebo. Phase II testing may last from several months to two years. Phase II trials involve 100-300 subjects with the disease or condition of interest. Includes PK, dose ranging, safety and efficacy.
Glossary
Phase II
-
Ampoule (Ampule)
...
-
-
HME
...
-
-
Validation
-
-
-
-
-
APIs
-
Toxicology
-
GDUFA
...
-
Inspections
-
Capsules
Microcapsule
...
-
Wurster Process
...
