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.
Cheryl Abernathy and Bryan Sasbon, Quality Assurance Operations Manager, Ropack Pharma Solutions; QA Director & Regulatory Affairs, Ropack Pharma Solutions||September 8, 2016 Embracing the process as a means to a strong quality culture