Saving changes...

Done

Error

2017 ACCP Virtual Journal Club March | Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development

2017 ACCP Virtual Journal Club March | Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development

2017 ACCP Virtual Journal Club March | Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development

Yeruk Mulugeta, PharmD, Jeffrey S. Barrett, PhD, Robert Nelson,MD, PhD, Abel Tilahun Eshete, PhD, Al
Yeruk Mulugeta, PharmD, Jeffrey S. Barrett, PhD, Robert Nelson,MD, PhD, Abel Tilahun Eshete, PhD, Al
on behalf of American College of Clinical Pharmacology

$20.00 $ 20.00 $ 20.00

$ 20.00 $ 20.00 $ 20.00
$ 20.00 $ 20.00 $ 20.00
Normal Price: $20.00 $20.00

Review:

Launch date: 19 Jul 2018
Expiry Date: 13 Mar 2020

Last updated: 16 Apr 2019

Reference: 191038

This course is no longer available

Exam is embedded in the course
No preview available
No Exam Available

Latest User Comments

I would like to...

Course Availability

This course is only available to trainees days after purchase. It would need to be repurchased by the trainee if not completed in the allotted time period. This course is no longer available. You will need to repurchase if you wish to take the course again.

You have null days left.

Description

During drug development, matching adult systemic exposures of drugs is a common approach for dose selection in pediatric patients when efficacy is partially or fully extrapolated. This is a systematic review of approaches used for matching adult systemic exposures as the basis for dose selection in pediatric trials submitted to the US Food and Drug Administration (FDA) between 1998 and 2012. The trial design of pediatric pharmacokinetic (PK) studies and the pediatric and adult systemic exposure data were obtained from FDA publicly available databases containing reviews of pediatric trials. Exposure-matching approaches that were used as the basis for pediatric dose selection were reviewed. The PK data from the adult and pediatric populations were used to quantify exposure agreement between the 2 patient populations. The main measures were the pediatric PK studies' trial design elements and drug systemic exposures (adult and pediatric). There were 31 products (86 trials) with full or partial extrapolation of efficacy with an available PK assessment. Pediatric exposures had a range of mean Cmax and AUC ratios (pediatric/adult) of 0.63 to 4.19 and 0.36 to 3.60, respectively. Seven of the 86 trials (8.1%) had a predefined acceptance boundary used to match adult exposures. The key PK parameter was consistently predefined for antiviral and anti-infective products. Approaches to match exposure in children and adults varied across products. A consistent approach for systemic exposure matching and evaluating pediatric PK studies is needed to guide future pediatric trials.

Objectives

Discuss various approaches to exposure matching for extrapolating efficacy to pediatric patients from adult data
On completion of this course, the learner will be able to discuss various approaches to exposure matching for extrapolating efficacy to pediatric patients from adult data
Describe the regulatory history of exposure matching and applicability to pediatric extrapolation
On completion of this course, the learner will be able to describe the regulatory history of exposure matching and applicability to pediatric extrapolation
List the pros and cons of establishing predefined acceptance boundaries for exposure matching in pediatric partial and full extrapolation of adult efficacy
On completion of this course, the learner will be able to list the pros and cons of establishing predefined acceptance boundaries for exposure matching in pediatric partial and full extrapolation of adult efficacy
Yeruk Mulugeta, PharmD, Jeffrey S. Barrett, PhD, Robert Nelson,MD, PhD, Abel Tilahun Eshete, PhD, Al

Author Information Play Video Bio

Yeruk Mulugeta, PharmD, Jeffrey S. Barrett, PhD, Robert Nelson,MD, PhD, Abel Tilahun Eshete, PhD, Al
on behalf of American College of Clinical Pharmacology

Yeruk Mulugeta -
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and
Research, US Food and Drug Administration, Silver Spring, MD, USA.

Jeffrey S. Barrett -
Division of Clinical Pharmacology & Therapeutics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.

Robert Nelson -
Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA.


Abel Tilahun Eshete -
Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Alvina Mushtaq -
Children's National Medical Center, Washington, DC, USA.

Lynne Yao, -
Pediatric and Maternal Health Staff, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Nicole Glasgow -
University of Maryland School of Pharmacy, Baltimore, MD, USA.

Andrew E. Mulberg -
Division of Gastroenterology and Inborn Errors Products, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.


Daniel Gonzalez -
Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, USA.


Dionna Green -
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Jeffry Florian -
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Kevin Krudys -
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Shirley Seo -
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Insook Kim -
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.


Dakshina Chilukuri -
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Gilbert J. Burckart -
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Current Accreditations

This course has been certified by or provided by the following Certified Organization/s:

  • Accreditation Council for Continuing Medical Education (ACCME)
  • 1.00 Credits
  • Accreditation Council for Pharmacy Education (ACPE)
  • 1.00 Hours -
    Exam Pass Rate: 75
    -
    Reference: 0238-0000-17-021-H01-P

Faculty and Disclosures

Presenters: Gilbert J. Burckart, PharmD and Kevin Krudys, PhD

Presenters: Gilbert J. Burckart, PharmD and Kevin Krudys, PhD

have nothing to disclose.
Moderator: Chaturvedula, Ayyappa, MA, BSP, RPh

Moderator: Chaturvedula, Ayyappa, MA, BSP, RPh

has nothing to disclose
Reviewer: Michael Jann, PharmD,

Reviewer: Michael Jann, PharmD,

Michael Jann, PharmD, Professor & Chair, Dept of Pediatrics, Univ of North Texas System Coll of Pharmacy, who developed the continuing education portion of this activity (target audience, goals and objectives and questions with solutions), discloses that he receives a Honoria from Janssen Pharmaceutical for a Speaker’s Bureau.

Additional Contributors

Conflicts Declared

Conflicts of Interest declaration by Author:

null

User Reviews (0)

Go Back

Loading...


Saving changes...

Done

Error