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Strength Biowaivers For Immediate Release Oral Solid Drug Products European American Perspectives

A strength biowaiver is usually claimed for an additional strength when bioequivalence has been established for one strength and the biopharmaceutics.

United statesBilel khedirVan alstineJournal of pharmacy pharmaceutical sciencesEuropean journal of pharmaceutical sciencesEuropean medicines agencyOpalia pharma recordati groupDrug administrationOpalia pharma recordatiOthe drugVitro dissolutionMethodology used to analyze dissolutionEuropean pharmacopeiaEuropean journalPharmaceutical sciencesAdditional strength biowaivers

The Discriminative Power Of Dissolution Methods In The US Europe

The discriminatory power is a factor that may be game changing for dissolution testing of immediate release tablets in quality control or R&D.

United statesBilel khedirStates pharmacopeiaOpalia pharma recordati groupDissolution methods in research and developmentEuropean medicines agencyDrug administrationEuropean medicine agencyOpalia pharma recordatiAmerican perspectiveEuropean perspectiveDissolution methodDissolution testingAcceptance criteriaEuropean pharmacopeiaDosage forms

4 Focus Areas To Modernize Your Cleaning Validation Strategy

The traditional outlook on cleaning validation might look inexpensive and safe, but it can lead to serious problems in the long run. To modernize.

Dalenda bouslahAlya el heddaFrank wilczekBilel khedirOpalia pharma recordati groupBrazilian journal of pharmaceutical sciencesOpalia pharma recordatiJames clearCleaning validation data managementAnalytical toolsBrazilian journalPharmaceutical sciences

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