Relationships between in vitro drug dissolution and in vivo response.
In recent years there has been an effort to relate manufacturing variables to the performance of the dosage form from a clinical point of view (in terms of safety and efficacy). Consequently any control strategy or the establishment of meaningful specifications should take into consideration the clinical impact on the patient. Since plasma levels are considered to be one of the most useful surrogates for clinical safety (in that bioequivalent plasma levels are considered therapeutically equivalent) and dissolution is the best surrogate for bioavailability, it is a natural consequence that dissolution be used to establish the design space in which all the formulations would have similar safety and efficacy profiles.
Peter
P
Langguth
Patrick
P
Marroum
D001682:Biological Availability; D004304:Dosage Forms; D015195:Drug Design; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D006801:Humans; D004364:Pharmaceutical Preparations / Q000097:blood* / Q000737:chemistry*; D012995:Solubility; D013810:Therapeutic Equivalency
D004304:Dosage Forms; D004364:Pharmaceutical Preparations