FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2292153263> ?p ?o ?g. }

• W2292153263 abstract "Literature data relevant to the decision to allow a waiver of in vivo bioequiva- lence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing metronidazole are reviewed. Metronidazole can be assigned to Biopharmaceutics Classifica- tion System Class I. Most BE studies that were identified reported the investigated formu- lations to be bioequivalent, indicating the risk of bioinequivalence to be low. Formulations showing differences in bioavailability showed dissimilarities in in vitro dissolution profiles. Furthermore, metronidazole has a wide therapeutic index. It is concluded that a biowaiver for solid IR formulations is justified, provided: (a) the test product and its comparator are both rapidly dissolving; (b) meet similarity of the dissolution profiles at pH 1.2, 4.5, and 6.8; (c) the test product contains only excipients present in IR drug products approved in Interna- tional Conference on Harmonisation (ICH) or associated countries in the same dosage form; and (d) if the test product contains sorbitol, sodium laurilsulfate, or propylene glycol. The test product needs to be qualitatively and quantitatively identical to its comparator with re- spect to these excipients. © 2011 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 100:1618-1627, 2011" @default.
• W2292153263 created "2016-06-24" @default.
• W2292153263 creator A5014715117 @default.
• W2292153263 creator A5020138765 @default.
• W2292153263 creator A5022850796 @default.
• W2292153263 creator A5034545677 @default.
• W2292153263 creator A5076183251 @default.
• W2292153263 creator A5076946026 @default.
• W2292153263 creator A5077536028 @default.
• W2292153263 creator A5081504966 @default.
• W2292153263 creator A5087021093 @default.
• W2292153263 creator A5089505115 @default.
• W2292153263 creator A5089728767 @default.
• W2292153263 date "2011-01-01" @default.
• W2292153263 modified "2023-09-27" @default.
• W2292153263 title "COMMENTARIES Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Metronidazole" @default.
• W2292153263 cites W121693803 @default.
• W2292153263 cites W1515288612 @default.
• W2292153263 cites W1576092319 @default.
• W2292153263 cites W1608577670 @default.
• W2292153263 cites W1971181330 @default.
• W2292153263 cites W1983073298 @default.
• W2292153263 cites W1997706322 @default.
• W2292153263 cites W2014086561 @default.
• W2292153263 cites W2016663357 @default.
• W2292153263 cites W2022686948 @default.
• W2292153263 cites W2027127607 @default.
• W2292153263 cites W2028133542 @default.
• W2292153263 cites W2050002385 @default.
• W2292153263 cites W2054408801 @default.
• W2292153263 cites W2057247555 @default.
• W2292153263 cites W2060992818 @default.
• W2292153263 cites W2064288191 @default.
• W2292153263 cites W2066242143 @default.
• W2292153263 cites W2067989704 @default.
• W2292153263 cites W2080708358 @default.
• W2292153263 cites W2084569396 @default.
• W2292153263 cites W2086507424 @default.
• W2292153263 cites W2091675945 @default.
• W2292153263 cites W2091753184 @default.
• W2292153263 cites W2092379271 @default.
• W2292153263 cites W2111977806 @default.
• W2292153263 cites W2126909053 @default.
• W2292153263 cites W2169939486 @default.
• W2292153263 cites W2171261526 @default.
• W2292153263 cites W2322714974 @default.
• W2292153263 cites W2346825864 @default.
• W2292153263 cites W620749124 @default.
• W2292153263 cites W9964867 @default.
• W2292153263 cites W2410408585 @default.
• W2292153263 cites W612616819 @default.
• W2292153263 hasPublicationYear "2011" @default.
• W2292153263 type Work @default.
• W2292153263 sameAs 2292153263 @default.
• W2292153263 citedByCount "0" @default.
• W2292153263 crossrefType "journal-article" @default.
• W2292153263 hasAuthorship W2292153263A5014715117 @default.
• W2292153263 hasAuthorship W2292153263A5020138765 @default.
• W2292153263 hasAuthorship W2292153263A5022850796 @default.
• W2292153263 hasAuthorship W2292153263A5034545677 @default.
• W2292153263 hasAuthorship W2292153263A5076183251 @default.
• W2292153263 hasAuthorship W2292153263A5076946026 @default.
• W2292153263 hasAuthorship W2292153263A5077536028 @default.
• W2292153263 hasAuthorship W2292153263A5081504966 @default.
• W2292153263 hasAuthorship W2292153263A5087021093 @default.
• W2292153263 hasAuthorship W2292153263A5089505115 @default.
• W2292153263 hasAuthorship W2292153263A5089728767 @default.
• W2292153263 hasConcept C116073593 @default.
• W2292153263 hasConcept C14029885 @default.
• W2292153263 hasConcept C160492267 @default.
• W2292153263 hasConcept C181389837 @default.
• W2292153263 hasConcept C185592680 @default.
• W2292153263 hasConcept C202751555 @default.
• W2292153263 hasConcept C2777396551 @default.
• W2292153263 hasConcept C2780035454 @default.
• W2292153263 hasConcept C2781430271 @default.
• W2292153263 hasConcept C2910701995 @default.
• W2292153263 hasConcept C42404028 @default.
• W2292153263 hasConcept C43617362 @default.
• W2292153263 hasConcept C501593827 @default.
• W2292153263 hasConcept C55493867 @default.
• W2292153263 hasConcept C71924100 @default.
• W2292153263 hasConcept C77281830 @default.
• W2292153263 hasConcept C98274493 @default.
• W2292153263 hasConceptScore W2292153263C116073593 @default.
• W2292153263 hasConceptScore W2292153263C14029885 @default.
• W2292153263 hasConceptScore W2292153263C160492267 @default.
• W2292153263 hasConceptScore W2292153263C181389837 @default.
• W2292153263 hasConceptScore W2292153263C185592680 @default.
• W2292153263 hasConceptScore W2292153263C202751555 @default.
• W2292153263 hasConceptScore W2292153263C2777396551 @default.
• W2292153263 hasConceptScore W2292153263C2780035454 @default.
• W2292153263 hasConceptScore W2292153263C2781430271 @default.
• W2292153263 hasConceptScore W2292153263C2910701995 @default.
• W2292153263 hasConceptScore W2292153263C42404028 @default.
• W2292153263 hasConceptScore W2292153263C43617362 @default.
• W2292153263 hasConceptScore W2292153263C501593827 @default.
• W2292153263 hasConceptScore W2292153263C55493867 @default.
• W2292153263 hasConceptScore W2292153263C71924100 @default.
• W2292153263 hasConceptScore W2292153263C77281830 @default.

• next