Forum Update: Supporting Community-Led Discussion
The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.
Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:
- Correct any misunderstandings
- Provide guidance when questions remain unanswered after a few days
- Support discussions where official clarification is needed
Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.
Thank you for being part of the conversation.
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)?
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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.