[Revalidation of the in vitro specification limits after an in vitro-in vivo correlation].
A "Level A" in vitro/in vivo correlation was established for a sustained release theophylline (CAS 58-55-9) preparation (Bronchoretard) under investigation. Such a functional relationship is a valuable tool for predicting the in vivo performance of a product. Additionally, the in vitro specification limits could be justified or even enlarged based on such an extrapolation.
L.A.B. GmbH & Co., Neu-Ulm.
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D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D003692:Delayed-Action Preparations; D006801:Humans; D008297:Male; D015203:Reproducibility of Results; D012995:Solubility; D013806:Theophylline / Q000008:administration & dosage / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
D018927:Anti-Asthmatic Agents; D003692:Delayed-Action Preparations; D013806:Theophylline