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Relationships between in vitro drug dissolution and in vivo response
Author(s) -
Langguth Peter,
Marroum Patrick
Publication year - 2012
Publication title -
biopharmaceutics and drug disposition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.419
H-Index - 58
eISSN - 1099-081X
pISSN - 0142-2782
DOI - 10.1002/bdd.1808
Subject(s) - bioequivalence , bioavailability , pharmacology , drug , plasma concentration , in vivo , dissolution , clinical trial , biochemical engineering , risk analysis (engineering) , medicine , computer science , chemistry , microbiology and biotechnology , engineering , biology
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. Copyright © 2012 John Wiley & Sons, Ltd.