Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Diclofenac Sodium and Diclofenac Potassium

Literature data are reviewed regarding the scientific advisability of allowing a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing either diclofenac potassium and diclofenac sodium. Within the biopharmaceutics classification s...

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Veröffentlicht in:	Journal of pharmaceutical sciences 2009-04, Vol.98 (4), p.1206-1219
Hauptverfasser:	B.Chuasuwan, Binjesoh, V., Polli, J.E., Zhang, H., Amidon, G.L., Junginger, H.E., Midha, K.K., Shah, V.P., Stavchansky, S., Dressman, J.B., Barends, D.M.
Format:	Artikel
Sprache:	eng
Schlagworte:	absorption Administration, Oral Animals Anti-Inflammatory Agents, Non-Steroidal - administration & dosage Anti-Inflammatory Agents, Non-Steroidal - adverse effects Anti-Inflammatory Agents, Non-Steroidal - chemistry Anti-Inflammatory Agents, Non-Steroidal - pharmacokinetics bioequivalence Biological Availability biopharmaceutics biopharmaceutics classification system (BCS) Chemical Phenomena classification diclofenac Diclofenac - administration & dosage Diclofenac - adverse effects Diclofenac - chemistry Diclofenac - pharmacokinetics Excipients - chemistry Humans permeability regulatory science Solubility system (BCS) Tablets Therapeutic Equivalency
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