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Items: 20

1.

Biowaiver monographs for immediate release solid oral dosage forms: aciclovir.

Arnal J, Gonzalez-Alvarez I, Bermejo M, Amidon GL, Junginger HE, Kopp S, Midha KK, Shah VP, Stavchansky S, Dressman JB, Barends DM.

J Pharm Sci. 2008 Dec;97(12):5061-73. doi: 10.1002/jps.21392.

2.

Biowaiver monographs for immediate-release solid oral dosage forms: ketoprofen.

Shohin IE, Kulinich JI, Ramenskaya GV, Abrahamsson B, Kopp S, Langguth P, Polli JE, Shah VP, Groot DW, Barends DM, Dressman JB.

J Pharm Sci. 2012 Oct;101(10):3593-603. doi: 10.1002/jps.23233. Epub 2012 Jul 11. Review.

PMID:
22786667
3.

Biowaiver monographs for immediate release solid oral dosage forms: lamivudine.

Strauch S, Jantratid E, Dressman JB, Junginger HE, Kopp S, Midha KK, Shah VP, Stavchansky S, Barends DM.

J Pharm Sci. 2011 Jun;100(6):2054-63. doi: 10.1002/jps.22449. Epub 2011 Feb 9. Review.

PMID:
21491435
4.

Biowaiver monographs for immediate release solid oral dosage forms: Doxycycline hyclate.

Jantratid E, Strauch S, Becker C, Dressman JB, Amidon GL, Junginger HE, Kopp S, Midha KK, Shah VP, Stavchansky S, Barends DM.

J Pharm Sci. 2010 Apr;99(4):1639-53. doi: 10.1002/jps.21954. Review.

5.

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Levetiracetam.

Petruševska M, Berglez S, Krisch I, Legen I, Megušar K, Peternel L, Abrahamsson B, Cristofoletti R, Groot DW, Kopp S, Langguth P, Mehta M, Polli JE, Shah VP, Dressman J.

J Pharm Sci. 2015 Sep;104(9):2676-87. doi: 10.1002/jps.24350. Epub 2015 Feb 6. Review.

PMID:
25663270
6.

Biowaiver monographs for immediate release solid oral dosage forms: prednisolone.

Vogt M, Derendorf H, Krämer J, Junginger HE, Midha KK, Shah VP, Stavchansky S, Dressman JB, Barends DM.

J Pharm Sci. 2007 Jan;96(1):27-37. Review.

PMID:
17039494
7.

Biowaiver monographs for immediate release solid oral dosage forms: ciprofloxacin hydrochloride.

Olivera ME, Manzo RH, Junginger HE, Midha KK, Shah VP, Stavchansky S, Dressman JB, Barends DM.

J Pharm Sci. 2011 Jan;100(1):22-33. doi: 10.1002/jps.22259. Review.

PMID:
20602455
8.

Biowaiver monographs for immediate release solid oral dosage forms: efavirenz.

Cristofoletti R, Nair A, Abrahamsson B, Groot DW, Kopp S, Langguth P, Polli JE, Shah VP, Dressman JB.

J Pharm Sci. 2013 Feb;102(2):318-29. doi: 10.1002/jps.23380. Epub 2012 Nov 22. Review.

PMID:
23175470
9.

Biowaiver monographs for immediate release solid oral dosage forms: mefloquine hydrochloride.

Strauch S, Jantratid E, Dressman JB, Junginger HE, Kopp S, Midha KK, Shah VP, Stavchansky S, Barends DM.

J Pharm Sci. 2011 Jan;100(1):11-21. doi: 10.1002/jps.22249. Review.

PMID:
20602454
10.

Biowaiver monographs for immediate-release solid oral dosage forms: Zidovudine (azidothymidine).

Soares KC, Rediguieri CF, Souza J, Serra CH, Abrahamsson B, Groot DW, Kopp S, Langguth P, Polli JE, Shah VP, Dressman J.

J Pharm Sci. 2013 Aug;102(8):2409-23. doi: 10.1002/jps.23624. Epub 2013 Jun 10. Review.

PMID:
23754446
11.

Biowaiver monographs for immediate release solid oral dosage forms: amodiaquine hydrochloride.

Nair A, Abrahamsson B, Barends DM, Groot DW, Kopp S, Polli JE, Shah VP, Dressman JB.

J Pharm Sci. 2012 Dec;101(12):4390-401. doi: 10.1002/jps.23312. Epub 2012 Sep 4. Review.

PMID:
22949374
12.

The biopharmaceutics classification system (BCS): class III drugs - better candidates for BA/BE waiver?

Blume HH, Schug BS.

Eur J Pharm Sci. 1999 Dec;9(2):117-21. Review.

PMID:
10620723
14.

Regulatory Perspectives on Strength-Dependent Dissolution Profiles and Biowaiver Approaches for Immediate Release (IR) Oral Tablets in New Drug Applications.

Suarez-Sharp S, Delvadia PR, Dorantes A, Duan J, Externbrink A, Gao Z, Ghosh T, Miksinski SP, Seo P.

AAPS J. 2016 May;18(3):578-88. doi: 10.1208/s12248-016-9893-2. Epub 2016 Feb 29. Review.

15.

A science based approach to topical drug classification system (TCS).

Shah VP, Yacobi A, Rădulescu FŞ, Miron DS, Lane ME.

Int J Pharm. 2015 Aug 1;491(1-2):21-5. doi: 10.1016/j.ijpharm.2015.06.011. Epub 2015 Jun 10. Review.

PMID:
26070249
16.

The impact of the EMA change in definition of "dose" on the BCS dose-solubility ratio: a review of the biowaiver monographs.

Sediq A, Kubbinga M, Langguth P, Dressman J.

J Pharm Sci. 2014 Jan;103(1):65-70. doi: 10.1002/jps.23769. Epub 2013 Nov 8. Review.

PMID:
24338749
17.

Biowaiver: an alternative to in vivo pharmacokinetic bioequivalence studies.

Mishra V, Gupta U, Jain NK.

Pharmazie. 2010 Mar;65(3):155-61. Review.

PMID:
20383933
18.

Aciclovir. A reappraisal of its antiviral activity, pharmacokinetic properties and therapeutic efficacy.

Wagstaff AJ, Faulds D, Goa KL.

Drugs. 1994 Jan;47(1):153-205. Review.

PMID:
7510619
19.

Implementing the Biopharmaceutics Classification System in Drug Development: Reconciling Similarities, Differences, and Shared Challenges in the EMA and US-FDA-Recommended Approaches.

Cardot JM, Garcia Arieta A, Paixao P, Tasevska I, Davit B.

AAPS J. 2016 Jul;18(4):1039-46. doi: 10.1208/s12248-016-9915-0. Epub 2016 Apr 26. Review.

PMID:
27116020
20.

Applications of Polymers as Pharmaceutical Excipients in Solid Oral Dosage Forms.

Debotton N, Dahan A.

Med Res Rev. 2017 Jan;37(1):52-97. doi: 10.1002/med.21403. Epub 2016 Aug 9. Review.

PMID:
27502146

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