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  4. Advancing the Development of Pediatric Therapeutics (ADEPT) 8 Workshop on Drug Dosing in Pediatric Patients with Renal Impairment - 11/30/2023
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Workshop | In Person

Event Title
Advancing the Development of Pediatric Therapeutics (ADEPT) 8 Workshop on Drug Dosing in Pediatric Patients with Renal Impairment
November 30, 2023 - December 1, 2023


Date:
November 30, 2023 - December 1, 2023
Day1:
- ET
Day2:
- ET
Organized By:

Location 

FDA White Oak Campus 
Building 31, Conference Center, The Great Room   
10903 New Hampshire Ave. 
Silver Spring, MD 20993 

Organized by: CDER’s Office of New Drugs 
Host Office Division: University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the Food and Drug Administration (FDA)

Summary

The purpose of this public workshop is to discuss the current landscape of drug dosing in pediatric patients with renal impairment, understand the gaps in knowledge and consider innovative approaches to improve the current paradigm for dosing in pediatric patients with renal impairment. 

Goals and Objectives 

Advancing the Development of Pediatric Therapeutics Workshop on Drug Dosing in Pediatric Patients with Renal Impairment.

Meeting Agenda

Contact 

For additional details, contact the FDAs CDER/OND/Public Meeting Team at ONDPublicMTGSupport@fda.hhs.gov. 


Workshop Presentations

Unfortunately, we are unable to provide alternate text for the presentations in the workshop. Persons with disabilities having problems accessing this page may call (301) 796-3634 for assistance.

Day 1: Thursday, November 30, 2023

Setting the Scene

Opening Presentation

Drug clearance in pediatric patients with renal impairment

Case example: Avycaz (Abbvie)

Session 1: What constitutes as renal impairment in pediatric patients for the purposes of PK characterization and drug dosing?

Academic Perspective: Considerations around assessment of renal function
Clinical Perspective:  Considerations around assessment of renal function and drug dosing
Industry Perspective: Considerations around assessment of renal function in the context of clinical trial 

Session 2: Translating adult renal impairment data in pediatric patients with renal impairment

Recap of Case Example: Avycaz (Abbie)

Translating adult renal impairment PK data—Academic/clinical perspective

Reliance on BSA indexed GFR values versus individualized eGFR values to guide drug dosing in adults and implications to pediatrics


Day 2: Friday, December 1, 2023

Session 3: Future Directions: Dosing in pediatric patients with renal impairment

Role of modeling and simulation

Considerations for modeling and simulation for pediatric renal impairment

Role of systems biology modeling in extrapolating efficacy and safety from adult renal impairment data

Approaches for generating clinical trial data to assess impact of RI on PK in pediatric patients

Industry perspective

Labeling considerations


Event Materials

Title File Type/Size
ADEPT 8 Workshop Agenda pdf (218.61 KB)
ADEPT 8 Speaker Biographies pdf (1.21 MB)
Strengths and Limitations of Existing Estimation Methods and Applications to Specific Populations - Schwartz pdf (1.14 MB)
ADEPT 8: Workshop on Drug Dosing in Pediatric Patients with Renal Impairment - Tuchman.pdf pdf (619.00 KB)
Drug Dosing in Pediatric Patients with Impaired Renal Function: Ceftazidime-Avibactam Case Example - Abodakpi pdf (2.26 MB)
Assessment of the Impact of Renal Impairment and Drug Dosage Considerations - Sahre pdf (432.81 KB)
What clinicians and other stakeholders needs to know about special populations - Filler pdf (3.60 MB)
Translating adult renal impairment PK data - De Wildt pdf (2.66 MB)
Bioanalytical Aspects and other non-GFR considerations in deciding on the Formula To use in GFR Assessment in Pediatric Patients - Sharma pdf (354.48 KB)
Reliance on BSA Indexed GFR Valuesvs Individualized eGFR Values to Guide Drug Dosing in Adults and Implications to Pediatrics - Nolin pdf (2.05 MB)
Drug clearance in pediatric patients with renal impairment - De Wildt pdf (2.76 MB)
The Kidneys and Clinical Trials | Who, What, Where, When, Why? - Webb and Chand pdf (829.29 KB)
Campus Opportunities for generating clinical trial data to assess impact of renal impairment on pharmacokinetics in pediatric patients - Marquard pdf (881.49 KB)
Renal Dosing in Pediatric Patients: Labeling Considerations - Choi pdf (645.54 KB)
Considerations for Modeling & Simulation for Pediatric Renal Impairment - Earp pdf (1.17 MB)
Role of systems biology modeling in extrapolating efficacy and safety from adult renal impairment data - Azer pdf (2.36 MB)
Recap of Case Example: Avycaz (Abbie) - Abodakpi pdf (2.28 MB)
 
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