№ lp_1_2_46550
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The document outlines the template and requirements for the submission of a Quality Information Summary (QIS) for biotherapeutic products or similar biotherapeutic products (SBPs) that are approved by stringent regulatory authorities, aimed at prequalification by the World Health Organization (WHO).
Year: 2023
Region / City: Global
Topic: Biotherapeutic Product Prequalification
Document Type: Guidelines
Organization / Institution: World Health Organization (WHO)
Author: WHO
Target Audience: Regulatory Authorities, Pharmaceutical Companies
Validity Period: Ongoing
Approval Date: Not specified
Date of Changes: Not specified
Price: 8 / 10 USD
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Quality Information Summary (QIS) of the Biotherapeutic Product Approved by Stringent Regulatory Authority (SRA)(QIS-BTP-SRA)
Year: 2021
Region / city: Worldwide
Topic: Biotherapeutic Product Documentation
Document type: Guidelines
Organization / institution: World Health Organization (WHO)
Author: World Health Organization (WHO)
Target audience: Regulatory authorities, pharmaceutical companies, healthcare professionals
Period of validity: Not specified
Approval date: Not specified
Date of changes: Not specified
Quality Information Summary (QIS) of the Biotherapeutic Product Approved by Stringent Regulatory Authority (SRA)(QIS-BTP-SRA)
Year: 2021
Region / city: Worldwide
Topic: Biotherapeutic Product Documentation
Document type: Guidelines
Organization / institution: World Health Organization (WHO)
Author: World Health Organization (WHO)
Target audience: Regulatory authorities, pharmaceutical companies, healthcare professionals
Period of validity: Not specified
Approval date: Not specified
Date of changes: Not specified
Quality Information Summary (QIS) of the Biotherapeutic Product Approved by Stringent Regulatory Authority (SRA) (QIS-BTP-SRA)
Year: 2021
Region / City: N/A
Topic: Biotherapeutic Product Prequalification
Document Type: Template
Organization / Institution: World Health Organization (WHO)
Author: WHO
Target Audience: Regulatory Authorities, Manufacturers
Effective Period: N/A
Approval Date: N/A
Date of Changes: N/A
RBX7455, a Room Temperature-Stable, Orally-Administered Investigational Live Biotherapeutic, Phase 1 Study for Recurrent Clostridioides difficile Infections
Year: 2026
Region / City: Rochester, MN, USA
Topic: Microbiome modulation in Clostridioides difficile infection
Document Type: Clinical trial report
Institution: Mayo Clinic; Rebiotix Inc; BioRankings LLC
Authors: Sahil Khanna, MBBS; Darrell S. Pardi, MD; Courtney Jones; William D. Shannon, PhD, MBA; Carlos Gonzalez, MS; Ken Blount, PhD
Target Audience: Medical researchers, gastroenterologists, microbiologists
Study Phase: Phase 1
Treatment: RBX7455 orally administered live biotherapeutic
Sample Type: Fecal samples from study participants
Outcome Measures: Safety, efficacy, microbiome composition shifts
Time Points: Baseline, Day 1, Week 1, Week 4, Week 8, Week 12, Week 24
Analysis Methods: Dirichlet multinomial fitting, repeated measures analysis (DMRepeat)
Publication References: La Rosa PS et al., PLoS One 2012; Shannon WD, BioRankings Technical Report #3
Quality Information Summary of Finished Pharmaceutical Products Approved by Stringent Regulatory Authorities (SRA)
Year: 2014
Region / City: Global
Topic: Pharmaceutical Product Prequalification
Document Type: Guideline
Organization / Institution: World Health Organization (WHO)
Author: World Health Organization
Target Audience: Pharmaceutical manufacturers, regulatory bodies
Effective Period: Not specified
Approval Date: 2014
Modification Date: Not specified
Quality Information Summary (QIS) of the Finished Pharmaceutical Product (FPP) Approved by the Reference Stringent Regulatory Authority (SRA) for use outside of the SRA Region(QIS-SRA-MED-crp)
Note: Year
Topic: Pharmaceutical product, regulatory approval, prequalification
Document type: Template
Organization / institution: WHO
Target audience: Regulatory authorities, pharmaceutical manufacturers
Quality Information Summary (QIS) of the Biotherapeutic Product Approved by Stringent Regulatory Authority (SRA)(QIS-BTP-SRA)
Year: 2021
Region / city: Worldwide
Topic: Biotherapeutic Product Documentation
Document type: Guidelines
Organization / institution: World Health Organization (WHO)
Author: World Health Organization (WHO)
Target audience: Regulatory authorities, pharmaceutical companies, healthcare professionals
Period of validity: Not specified
Approval date: Not specified
Date of changes: Not specified
Quality Information Summary (QIS) of the Biotherapeutic Product Approved by Stringent Regulatory Authority (SRA) (QIS-BTP-SRA)
Year: 2021
Region / City: N/A
Topic: Biotherapeutic Product Prequalification
Document Type: Template
Organization / Institution: World Health Organization (WHO)
Author: WHO
Target Audience: Regulatory Authorities, Manufacturers
Effective Period: N/A
Approval Date: N/A
Date of Changes: N/A
Table S1. Demographic, alcohol use, and network characteristics of the Full, Stringent, and Inclusive samples for the simulation study
Year: 2023
Region / city: N/A
Topic: Simulation study of demographic and network characteristics, alcohol use
Document type: Research table
Institution: N/A
Author: N/A
Target audience: Researchers, scholars in social science and network analysis
Period of validity: N/A
Approval date: N/A
Date of changes: N/A
Topics: SRAQIS-BTP-SRA Biotherapeutic Stringent