Biowaiver monographs for immediate release solid oral dosage forms: prednisolone.
Average rating
Cast your vote
You can rate an item by clicking the amount of stars they wish to award to this item.
When enough users have cast their vote on this item, the average rating will also be shown.
Star rating
Your vote was cast
Thank you for your feedback
Thank you for your feedback
Authors
Vogt, MDerendorf, H
Krämer, J
Junginger, H E
Midha, K K
Shah, V P
Stavchansky, S
Dressman, J B
Barends, D M
Type
ArticleLanguage
en
Metadata
Show full item recordTitle
Biowaiver monographs for immediate release solid oral dosage forms: prednisolone.Publiekssamenvatting
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing prednisolone are reviewed. Data on its solubility, oral absorption, and permeability are not totally conclusive, but strongly suggest a BCS Class 1 classification. Prednisolone's therapeutic indications and therapeutic index, pharmacokinetics, and the possibility of excipient interactions were also taken into consideration. Available evidence indicates that a biowaiver for IR solid oral dosage forms formulated with the excipients tabulated in this article would be unlikely to expose patients to undue risks.PMID
17039494ae974a485f413a2113503eed53cd6c53
10.1002/jps.20768
Scopus Count
Collections
Related articles
- Biowaiver monographs for immediate release solid oral dosage forms: prednisone.
- Authors: Vogt M, Derendorf H, Krämer J, Junginger HE, Midha KK, Shah VP, Stavchansky S, Dressman JB, Barends DM
- Issue date: 2007 Jun
- Biowaiver monographs for immediate release solid oral dosage forms: furosemide.
- Authors: Granero GE, Longhi MR, Mora MJ, Junginger HE, Midha KK, Shah VP, Stavchansky S, Dressman JB, Barends DM
- Issue date: 2010 Jun
- Biowaiver monographs for immediate release solid oral dosage forms: piroxicam.
- Authors: Shohin IE, Kulinich JI, Ramenskaya GV, Abrahamsson B, Kopp S, Langguth P, Polli JE, Shah VP, Groot DW, Barends DM, Dressman JB
- Issue date: 2014 Feb
- Biowaiver monographs for immediate release solid oral dosage forms: ciprofloxacin hydrochloride.
- Authors: Olivera ME, Manzo RH, Junginger HE, Midha KK, Shah VP, Stavchansky S, Dressman JB, Barends DM
- Issue date: 2011 Jan
- Biowaiver monographs for immediate-release solid oral dosage forms: stavudine.
- Authors: Silva AL, Cristofoletti R, Storpirtis S, Sousa VD, Junginger HE, Shah VP, Stavchansky S, Dressman JB, Barends DM
- Issue date: 2012 Jan