caa a22 4500 465812562 CHVBK 20180323112120.0 cr unu---uuuuu 170327e19900401xx s 000 0 eng 10.1007/BF03190201 doi (NATIONALLICENCE)springer-10.1007/BF03190201 Steinijans V. Dept. of Biometry, Byk Gulden Pharmaceuticals, P.O. Box 6500, D-7750, Konstanz, Fed. Rep. of Germany aut Pharmacokinetic characterization of controlled-release formulations [Elektronische Daten] [V. Steinijans] Summary: The development of controlled — release formulations should be based on a clinico-pharmacological rationale such as increased compliance, reduced side effects and improved efficacy. The pharmacokinetic profile of a controlled — release formulation and its dose regimen should be compared under steady-state conditions with that of an immediate — release formulation or that of another controlled — release formulation. Apart from conventional characteristics such as AUC, tmax and Cmax, alternative characteristics are suggested such as residual concentration at the end of the dose interval, peak — trough fluctuation in steady state, plateau time, statistical moments, in vivo imput functions and intravenous infusion schemes which mimic the concentration / time profile after oral administration of the controlled — release formulation. The pharmacokinetic steady — state profile should be reproduced with and without food, from day to day, and at various dose levels. The in vitro specification should be based on in vivo requirements for "within — product bioequivalence”. Springer-Verlag, 1990 Pharmacokinetics nationallicence controlled-release formulations nationallicence in-vitro/in-vivo relationship nationallicence steady state nationallicence food effects nationallicence European Journal of Drug Metabolism and Pharmacokinetics Springer-Verlag 15/2(1990-04-01), 173-181 0378-7966 15:2<173 1990 15 13318 https://doi.org/10.1007/BF03190201 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/BF03190201 text/html Onlinezugriff via DOI NATIONALLICENCE 100 1- Steinijans V. Dept. of Biometry, Byk Gulden Pharmaceuticals, P.O. Box 6500, D-7750, Konstanz, Fed. Rep. of Germany aut NATIONALLICENCE 773 0- European Journal of Drug Metabolism and Pharmacokinetics Springer-Verlag 15/2(1990-04-01), 173-181 0378-7966 15:2<173 1990 15 13318 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer