Skip to main content

Pediatric Formulations in Clinical Testing and the Challenge of Final Market Formulation

Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS,volume 11)

Abstract

Age-appropriate medicines are required to allow compliance with treatment and safe delivery of a pediatric drug product. As drug products for adults are often not suitable for use in children, new pediatric formulations must be specifically developed.

Keywords

  • Oral Dosage Form
  • Market Formulation
  • Pediatric Medicine
  • Dosage Strength
  • Pediatric Formulation

These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

This is a preview of subscription content, access via your institution.

Buying options

Chapter
USD   29.95
Price excludes VAT (USA)
  • DOI: 10.1007/978-1-4899-8011-3_14
  • Chapter length: 11 pages
  • Instant PDF download
  • Readable on all devices
  • Own it forever
  • Exclusive offer for individuals only
  • Tax calculation will be finalised during checkout
eBook
USD   169.00
Price excludes VAT (USA)
  • ISBN: 978-1-4899-8011-3
  • Instant PDF download
  • Readable on all devices
  • Own it forever
  • Exclusive offer for individuals only
  • Tax calculation will be finalised during checkout
Softcover Book
USD   219.99
Price excludes VAT (USA)
Hardcover Book
USD   219.99
Price excludes VAT (USA)
Fig. 14.1
Fig. 14.2
Fig. 14.3
Fig. 14.4
Fig. 14.5
Fig. 14.6
Fig. 14.7
Fig. 14.8
Fig. 14.9
Fig. 14.10
Fig. 14.11

References

  1. Ricci B (2012) Bridging studies in support of pediatric formulation development. In: EuPFI 4th conference, Prague

    Google Scholar 

  2. Guideline on pharmaceutical development of medicines for pediatric use; EMA/CHMP/QWP805880/2012, p 4/24

    Google Scholar 

  3. Rose K (2012) A paediatric investigation plan case study. Pharm Med 26(5):287–295

    CrossRef  Google Scholar 

  4. Sam T (2011) Exploring a risk management: approach towards developing the optimal paediatric formulation – applying quality by design and multi-criteria decision making. In: EuPFI 3rd conference, Strasbourg

    Google Scholar 

  5. Klingmann V, Spomer N, Stoltenberg I, Lerch C, Meissner T, Breitkreutz J (2011) Acceptance of drug-free minitablets in young children. In: EuPFI 3rd conference, Strasbourg

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Norbert Pöllinger .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and Permissions

Copyright information

© 2014 American Association of Pharmaceutical Scientists

About this chapter

Cite this chapter

Pöllinger, N. (2014). Pediatric Formulations in Clinical Testing and the Challenge of Final Market Formulation. In: Bar-Shalom, D., Rose, K. (eds) Pediatric Formulations. AAPS Advances in the Pharmaceutical Sciences Series, vol 11. Springer, New York, NY. https://doi.org/10.1007/978-1-4899-8011-3_14

Download citation