6533b85dfe1ef96bd12be63a
RESEARCH PRODUCT
Relationships betweenin vitrodrug dissolution andin vivoresponse
Peter LangguthPatrick J. Marroumsubject
Pharmacologybusiness.industryPharmaceutical ScienceGeneral MedicinePlasma levelsPharmacologyBioequivalenceDosage formBioavailabilityIn vivoClinical safetyMedicinePharmacology (medical)Dissolution testingBiochemical engineeringbusinessDesign spacedescription
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.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2012-09-13 | Biopharmaceutics & Drug Disposition |