The two strengths of the liquid multi-dose formulation of r-hGH are bioequivalent to the FD multi-dose reference formulation and are well tolerated. This conclusion is robust to adjustments for the active content and the actual dose administered.
Trial registration number
This bioequivalence study was conducted at AAIPharma, Neu-Ulm Germany. Bioanalytics were performed at Bureco, Reinach, Switzerland. The authors take full responsibility for the content of the paper but thank Andrew Desson of Merck Serono S.A. - Geneva, Switzerland (an affiliate of Merck KGaA, Darmstadt, Germany) for project management and Polly Field, DPhil, of Caudex Medical (funded by Merck Serono S.A. - Geneva, Switzerland, an affiliate of Merck KGaA, Darmstadt, Germany) for assistance in preparing the initial draft of the manuscript and collating the comments of the authors.
BL was study director in the terminal phase of the study, and was involved in the data analysis, interpretation and reporting of results. UF was involved in the design and conduct of the study, performed the medical supervision and contributed to the data analysis, interpretation and reporting of results. PW drafted the statistical design of the study, performed power calculations and was involved in the data analysis and interpretation of results. MG carried out bioanalytical assay development and validation followed by sample analysis and provided bioanalytical data for evaluation. AK was involved in and responsible for the study design and PK data analysis, and contributed to the interpretation and reporting of results. All authors read, reviewed and approved the final manuscript.
All authors are employees of Merck KGaA, Darmstadt or Grafing, Germany.
BMC Clin Pharmacol. 2010;10(14):1-7. © 2010
BioMed Central Ltd.
Cite this: Comparison of the Pharmacokinetics, Safety and Tolerability of Two Concentrations of a New Liquid Recombinant Human Growth Hormone Formulation versus the Freeze-dried Formulation - Medscape - Oct 20, 2010.