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Controlled/Modified Release Products
Recommendation in Support of EC-Guidelines
Mitwirkender: Blume, Henning; Möller, Helga; Gundert-Remy, Ursula
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The present proceedings represent ideas and recommendations for conducting investigations of Controlled/Modified Release Products subjected to: Definitions, Pharmaceutical Characerization, In Vivo/In Vitro Association, Biopharmaceutical Characterization, e.g. Study Design, Main Variables, Single/Multiple Dosing Statistical Evaluation and Decision Criteria and Clinical Characterization of New and Known Drug Substances.