Description
The purpose of this guidance is to provide general recommendations on the development of anti-infective drug products, including antibacterial, antifungal, and antiparasitic products, for the pediatric population.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
5A type of ATMP involving recombinant nucleic acids or viral vectors.
including antibacterial, antifungal, and antiparasitic products
including antibacterial, antifungal, and antiparasitic products
including antibacterial, antifungal, and antiparasitic products
Development of anti-infective drug products for the pediatric population
Stakeholders
3Participants 12 years and older to be included in Phase 3 adult trials.
Youngest pediatric group requiring cautious bridging
Entity responsible for submitting applications under section 524B
Regulatory Context
Regulatory Activities
2Adult trials that should include adolescent participants.
Timeline trigger for iPSP submission
Document Types
2Required information in meeting requests; Required content for the meeting package.
Sponsors must submit iPSPs early in development
Attributes
1Characteristic of orally administered dosage forms for children
Technical Details
Testing Methods
1Approaches used to select pediatric doses based on exposure matching.
Processes
1Nonclinical studies used to assess the safety of products for breastfeeding.
Clinical Concepts
7Disease with different pathophysiology in neonates compared to adults.
Example of infection where disease process may be similar between adult and pediatric populations.
Example of infection where disease process may be similar between adult and pediatric populations.
Example of disease where efficacy can be extrapolated
Example of disease where efficacy can be extrapolated
Target population for long-term neurodevelopmental safety studies
Frequently underrepresented in trials.
Standards & References
External Standards
1The active comparator used in pediatric clinical trials at trial sites.
ICH References (3)
Guidance on when particular studies can be abbreviated or deferred for life-threatening diseases
Nonclinical Safety Testing in Support of Development of Pediatric Pharmaceuticals.
Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- E11A Pediatric Extrapolation
- M15 General Principles for Model-Informed Drug Development
- Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
- Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
- Rare Diseases: Considerations for the Development of Drugs and Biological Products
- Q3C Impurities: Residual Solvents_2011
- Providing Regulatory Submissions in Electronic Format --Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling: Guidance for Industry
- Q4B Annex 5: Disintegration Test General Chapter