Dossche, Lien

Gasthuys, Elke

Michelet, Robin

Vande Walle, Johan

English

Ghent University Academic Bibliography

DESMOPRESSIN WHAT IS NEW? Paediatric drug development:    towards maturity DEPARTMENT OF PHARMACOLOGY, TOXICOLOGY AND BIOCHEMISTRY ELKE GASTHUYS DEPARTMENT OF BIOANALYSIS ROBIN MICHELET DEPARTMENT OF PAEDIATRIC NEPHROLOGY LIEN DOSSCHE Complete response (⅓) 100% reduction  Partial response (⅓) 50 to 99% reduction No-response (⅓) <50% reduction MNE DESMOPRESSIN: INTRO Complete response (⅓) 100% reduction  Partial response (⅓) 50 to 99% reduction No-response (⅓) <50% reduction MNE DESMOPRESSIN: INTRO Why do we observe no or partial anti-enuretic effect? DESMOPRESSIN: INTRO Timing of administration? Food interaction? Formulation? Dose? Fluid intake? Age-dependency? DESMOPRESSIN: INTRO Timing of administration? Food interaction? Formulation? Dose? Fluid intake? Age-dependency? Need for PK/PD characteristics of desmopressin SAFE-PEDRUG WP 9  Management and coordination  WP 1  Identification  of  the needs WP 2 Clinical trials the importance of surrogate  parameters WP  3 Juvenile animal model WP  4 PK/PD modelling WP  7 Guidelines WP  5 Critically ill children WP  6 Neonates WP 8 Ethical and legal aspects DESMOPRESSIN: PROBLEM SETTING Children grow and mature Size/age dependency of PK?  Food effect was shown on the PK in adults (Rittig et al., 1998) Children are often not fasted 1h before bedtime (recommended dosing time)!  Bioequivalence of two formulations (melt and tablet) in adults (120µg/200µg)   Is this true in the paediatric population?  Difficult to perform full PK studies  Can the piglet be a suitable animal model?    DESMOPRESSIN: AGE-DEPENDENCY Age-dependency only for the melt DESMOPRESSIN: FOOD INTERACTION Michelet et al. (2016) Michelet et al. (2016) DESMOPRESSIN: BIOEQUIVALENCE  DESMOPRESSIN: COMPARISON CHILDREN-PIGLETS Two absorption peaks Two absorption peaks Osterberg et al. (2006) Gasthuys et al. (2018) DESMOPRESSIN: CONCLUSIONS Children grow and mature Size/age dependency of PK? YES (melt)  Food effect was shown on the PK in adults (Rittig et al., 1998) Children are often not fasted 1h before bedtime (recommended dosing time)! YES (melt superior to tablet)  Bioequivalence of two formulations (melt and tablet) in adults (120µg/200µg)   Is this true in the paediatric population? NO (150 µg/200µg)  Difficult to perform full PK/PD studies  Can the piglet be a suitable animal model? YES (PK)    

Desmopressin what is new? : paediatric drug development : towards maturity

https://biblio.ugent.be/publication/8564047/file/8564049

Desmopressin what is new? : paediatric drug development : towards maturity

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Ghent University Academic Bibliography