Development of new medicinal products for the treatment of smoking - Scientific guideline
Human
Scientific guidelines
This document provides guidance in the definition of treatment goals, study design, outcome measures, and data analysis for new products that will be developed to treat nicotine dependence.
Keywords: Tobacco, smoking, nicotine dependence
Current effective version
Related content
- Clinical efficacy and safety: nervous system
- Directive 2001/83/EC
Guideline on the exposure to medicinal products during pregnancy: Need for post-authorisation data- Adjustment for baseline covariates in clinical trials
- Clinical evaluation of new vaccines
- ICH E1 Population exposure: the extent of population exposure to assess clinical safety
- ICH E4 Dose response information to support drug registration
- ICH E7 Studies in support of special populations: geriatrics
- ICH E10 Choice of control group in clinical trials
- ICH E11(R1) step 5 guideline on clinical investigation of medicinal products in the pediatric population - Scientific guideline
- Investigation of drug interactions
- Missing data in confirmatory clinical trials
- Pharmacokinetic studies in man