Applications of Accelerator Ms in Pediatric Drug Evaluation

Abstract

Accelerator MS (AMS) provides a novel method for obtaining and analyzing pharmacokinetics and pharmacodynamics in children. This paper reviews the scientific and ethical rationale for AMS in pediatric trials, the regulatory framework and general considerations with some specific examples of pediatric clinical trials using AMS. Microdosing in the context of this article refers to studies using a negligible amount (nanocuries) of ¹⁴C as tracer, and AMS as a quantitative technique. The technology is by no means a panacea for the deficiency in pediatric clinical research; however, it lessens the challenges and provides the most quantitative tool for pediatric pharmacology studies.

Financial & competing interests disclosure

During much of this work, LT Vuong was an officer of Vitalea Science, Inc., who sponsored many of the sample analyses referenced. At the present time, LT Vuong is a shareholder and member of the Board of Directors of Vitalea Science, Inc. AB Blood is an employee of Loma Linda Children’s Hospital, who provided clinical data and study design information of the neonatal study, which was funded by The Gerber Foundation. B Goldstein and ME Anderson are employees of Ikaria Pharmaceuticals. JS Vogel used to be an employee of Lawrence Livermore National Laboratories during much of the early work of accelerator MS. JS Vogel is now an unpaid scientific advisor to Vitalea Science, Inc. and possesses equity in the company, which licenses several of his patents. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Acknowledgements

The author acknowledges staff of Vitalea Science, Inc. in sample preparation for accelerator MS analyses for the neonatal study, in particularly S Abidi. In addition, special thanks to M Patterson of Vitalea Science, Inc. for assisting with the editing of the manuscript.

Additional information

Funding

During much of this work, LT Vuong was an officer of Vitalea Science, Inc., who sponsored many of the sample analyses referenced. At the present time, LT Vuong is a shareholder and member of the Board of Directors of Vitalea Science, Inc. AB Blood is an employee of Loma Linda Children’s Hospital, who provided clinical data and study design information of the neonatal study, which was funded by The Gerber Foundation. B Goldstein and ME Anderson are employees of Ikaria Pharmaceuticals. JS Vogel used to be an employee of Lawrence Livermore National Laboratories during much of the early work of accelerator MS. JS Vogel is now an unpaid scientific advisor to Vitalea Science, Inc. and possesses equity in the company, which licenses several of his patents. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.