IP toxicology efficacy side effect base on scientific data, nonclinical studies, effects in humans, summary of data and guidance for the investigator, investigators brochure is the compilation of chemistry-chemical properties, physical properties ,pharmaceutical properties and formulationof the drug
Investigators brochure is the compilation of Chemistry-chemical properties, physical properties ,pharmaceutical properties and formulationof the drug, Manufacturing details- tells about the details whether drugs are manufactured as per as GMP, Control-Stability ,humidity ,storage ,purity etc ,Nonclinical- and clinical Information
Physical, Chemical, and Pharmaceutical Properties and Formulation, Nonclinical Studies, Effects in Humans, Summary of Data and Guidance for the Investigator
Document of information of investigation products as toxicology efficacy side effect base on scientific data, this information for investigators/Medical doctor / pharmacist / investigation review board & independent ethics committee