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| 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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