Unattributed Code Systems

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Copyright and Registered Trademark Uses

External References

Type Reference Content
web github.com Response to Regulatory Questions (RTQ), published by HL7 International. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/rtq-ig/ and changes regularly. See the Directory of published versions
web github.com View the underlying FHIR Questionnaire resource (generated via FSH).
web www.ema.europa.eu See EMA Fee Guidance for payment confirmation requirements.
web www.ich.org Reference: ICH Q1A(R2)
web www.who.int Note: Confirm coverage for Zone IVb (30°C/75% RH) per WHO TRS 1010
web www.ich.org Threshold: >0.10% per ICH Q3B(R2)
web github.com Supports rich text answers, updated ePI translations, new stability data, and ICH/WHO climatic zone confirmation. View the underlying FHIR QuestionnaireResponse resource .
web www.ema.europa.eu See EMA Fee Guidance for payment confirmation requirements.
web doi.org References :
Anderson, M., Algorri, J.F., Abernathy, M. (2023). Real-time algorithmic exchange and processing of pharmaceutical quality data and information. International Journal of Pharmaceutics , 648, 123342. DOI: 10.1016/j.ijpharm.2023.123342

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