676 - Hi Patrick - Would you be able to explain the rationale behind Code s3.7, and why combination products cannot reference the brand names of their individual components (only the generic names)?
Jennifer Carroll last edited by
Hello. The rationale for section 3.7 is that different formulations could cause products to have different properties. One should not assume that two product having different non-medicinal ingredients have identical properties. For example, they may have different pharmacokinetic and / or clinical properties. Your second question is related to section 3.7 but also touches on other issues in critical appraisal. A clinical trial is an instrument designed to evaluate a hypothesis relating to that particular / precise independent variable. Just as you would not generate claims that extrapolate beyond the studied population, you should not generate claims that extrapolate beyond that independent variable.