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A new paediatric formulation of valaciclovir: development and bioequivalence assessment

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  • Contributors Formulation development was performed by DETB, CMB-W, KV-G, OSNMS and NV. For bioequivalence testing: DMB, APHC, CAWH, AW and DMB designed the study. DETB, APHC, CAWH and VEMH screened and enrolled patients. DETB, CMB-W and APHC oversaw data entry and undertook trial management. DETB, APHC, CMB-W, AW and DMB assisted with verification, analysis and interpretation of the data. DETB and CMB-W drafted the original version of the manuscript. All authors participated in the writing of the manuscript, and read and approved the final version.

  • Funding This study has been performed as part of the VALID (a new paediatric formulation of valacyclovir for the prophylaxis and treatment of VZV and HSV infections in children) project, which has been granted by The Netherlands Organisation for Health Research and Development (ZonMW), within the ‘Priority Medicines for Children’ Programme (project number: 113201004).

  • Competing interests None.

  • Ethics approval CMO Arnhem-Nijmegen, The Netherlands.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Stability data, exact composition and preparation method of the new valaciclovir liquid is freely available for everyone. For this, the Royal Dutch Pharmacists Association (Department: Laboratorium Nederlandse Apothekers (LNA Helpdesk)) can be approached (+31 70 373 73 70).