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Results: 1 to 20 of 95

1.
2.

A strategy for preclinical formulation development using GastroPlus as pharmacokinetic simulation tool and a statistical screening design applied to a dog study.

Kuentz M, Nick S, Parrott N, Röthlisberger D.

Eur J Pharm Sci. 2006 Jan;27(1):91-9. Epub 2005 Oct 10.

PMID:
16219449
[PubMed - indexed for MEDLINE]
3.

The role of biopharmaceutics in the development of a clinical nanoparticle formulation of MK-0869: a Beagle dog model predicts improved bioavailability and diminished food effect on absorption in human.

Wu Y, Loper A, Landis E, Hettrick L, Novak L, Lynn K, Chen C, Thompson K, Higgins R, Batra U, Shelukar S, Kwei G, Storey D.

Int J Pharm. 2004 Nov 5;285(1-2):135-46.

PMID:
15488686
[PubMed - indexed for MEDLINE]
4.

In silico predictions of gastrointestinal drug absorption in pharmaceutical product development: application of the mechanistic absorption model GI-Sim.

Sjögren E, Westergren J, Grant I, Hanisch G, Lindfors L, Lennernäs H, Abrahamsson B, Tannergren C.

Eur J Pharm Sci. 2013 Jul 16;49(4):679-98. doi: 10.1016/j.ejps.2013.05.019. Epub 2013 May 29.

PMID:
23727464
[PubMed - indexed for MEDLINE]
5.

Case studies for practical food effect assessments across BCS/BDDCS class compounds using in silico, in vitro, and preclinical in vivo data.

Heimbach T, Xia B, Lin TH, He H.

AAPS J. 2013 Jan;15(1):143-58. doi: 10.1208/s12248-012-9419-5. Epub 2012 Nov 10.

PMID:
23139017
[PubMed - indexed for MEDLINE]
Free PMC Article
6.

Using absorption simulation and gastric pH modulated dog model for formulation development to overcome achlorhydria effect.

Mitra A, Kesisoglou F, Beauchamp M, Zhu W, Chiti F, Wu Y.

Mol Pharm. 2011 Dec 5;8(6):2216-23. doi: 10.1021/mp200062a. Epub 2011 Oct 20.

PMID:
21981752
[PubMed - indexed for MEDLINE]
7.

Use of the Biopharmaceutical Classification System in early drug development.

Ku MS.

AAPS J. 2008;10(1):208-12. doi: 10.1208/s12248-008-9020-0. Epub 2008 Apr 3.

PMID:
18446521
[PubMed - indexed for MEDLINE]
Free PMC Article
8.

Physicochemical Properties, Form, and Formulation Selection Strategy for a Biopharmaceutical Classification System Class II Preclinical Drug Candidate.

Lohani S, Cooper H, Jin X, Nissley BP, Manser K, Rakes LH, Cummings JJ, Fauty SE, Bak A.

J Pharm Sci. 2014 Jul 29. doi: 10.1002/jps.24088. [Epub ahead of print]

PMID:
25074668
[PubMed - as supplied by publisher]
9.

A formulation strategy for gamma secretase inhibitor ELND006, a BCS class II compound: development of a nanosuspension formulation with improved oral bioavailability and reduced food effects in dogs.

Quinn K, Gullapalli RP, Merisko-Liversidge E, Goldbach E, Wong A, Liversidge GG, Hoffman W, Sauer JM, Bullock J, Tonn G.

J Pharm Sci. 2012 Apr;101(4):1462-74. doi: 10.1002/jps.23034. Epub 2011 Dec 28.

PMID:
22213574
[PubMed - indexed for MEDLINE]
10.

Development of clinical dosage forms for a poorly water soluble drug I: Application of polyethylene glycol-polysorbate 80 solid dispersion carrier system.

Dannenfelser RM, He H, Joshi Y, Bateman S, Serajuddin AT.

J Pharm Sci. 2004 May;93(5):1165-75.

PMID:
15067693
[PubMed - indexed for MEDLINE]
11.

Physiological modeling and assessments of regional drug bioavailability of danoprevir to determine whether a controlled release formulation is feasible.

Reddy MB, Connor A, Brennan BJ, Morcos PN, Zhou A, McLawhon P, Fretland A, Evans P, Smith P, Tran JQ.

Biopharm Drug Dispos. 2011 Jul;32(5):261-75. doi: 10.1002/bdd.756. Epub 2011 Jun 9.

PMID:
21660978
[PubMed - indexed for MEDLINE]
12.

Understanding the effect of API properties on bioavailability through absorption modeling.

Kesisoglou F, Wu Y.

AAPS J. 2008 Dec;10(4):516-25. doi: 10.1208/s12248-008-9061-4. Epub 2008 Nov 6. Review. Erratum in: AAPS J. 2009 Mar;11(1):31.

PMID:
19002590
[PubMed - indexed for MEDLINE]
Free PMC Article
13.

Suitability of a minipig model in assessing clinical bioperformance of matrix and multiparticulate extended-release formulations for a BCS class III Drug development candidate.

Kesisoglou F, Xie IH, Manser K, Wu Y, Hardy I, Fitzpatrick S.

J Pharm Sci. 2014 Feb;103(2):636-42. doi: 10.1002/jps.23837. Epub 2013 Dec 30.

PMID:
24382706
[PubMed - in process]
14.

Oral biopharmaceutics tools - time for a new initiative - an introduction to the IMI project OrBiTo.

Lennernäs H, Aarons L, Augustijns P, Beato S, Bolger M, Box K, Brewster M, Butler J, Dressman J, Holm R, Julia Frank K, Kendall R, Langguth P, Sydor J, Lindahl A, McAllister M, Muenster U, Müllertz A, Ojala K, Pepin X, Reppas C, Rostami-Hodjegan A, Verwei M, Weitschies W, Wilson C, Karlsson C, Abrahamsson B.

Eur J Pharm Sci. 2014 Jun 16;57:292-9. doi: 10.1016/j.ejps.2013.10.012. Epub 2013 Nov 1.

PMID:
24189462
[PubMed - in process]
15.

Crystalline nanosuspensions as potential toxicology and clinical oral formulations for BCS II/IV compounds.

Kesisoglou F, Mitra A.

AAPS J. 2012 Dec;14(4):677-87. doi: 10.1208/s12248-012-9383-0. Epub 2012 Jun 27. Review.

PMID:
22736294
[PubMed - indexed for MEDLINE]
Free PMC Article
16.

Bridging studies in support of oral pediatric formulation development.

Ricci BM.

Int J Pharm. 2013 Nov 30;457(1):323-6. doi: 10.1016/j.ijpharm.2013.07.074. Epub 2013 Aug 11.

PMID:
23942015
[PubMed - indexed for MEDLINE]
17.

Bioavailability enhancement of a poorly water-soluble drug by solid dispersion in polyethylene glycol-polysorbate 80 mixture.

Joshi HN, Tejwani RW, Davidovich M, Sahasrabudhe VP, Jemal M, Bathala MS, Varia SA, Serajuddin AT.

Int J Pharm. 2004 Jan 9;269(1):251-8.

PMID:
14698596
[PubMed - indexed for MEDLINE]
18.

An integrated early formulation strategy--from hit evaluation to preclinical candidate profiling.

Maas J, Kamm W, Hauck G.

Eur J Pharm Biopharm. 2007 Apr;66(1):1-10. Epub 2006 Oct 6. Review.

PMID:
17123801
[PubMed - indexed for MEDLINE]
19.

In vitro testing of drug absorption for drug 'developability' assessment: forming an interface between in vitro preclinical data and clinical outcome.

Sun D, Yu LX, Hussain MA, Wall DA, Smith RL, Amidon GL.

Curr Opin Drug Discov Devel. 2004 Jan;7(1):75-85. Review.

PMID:
14982151
[PubMed - indexed for MEDLINE]
20.

Drug absorption modeling as a tool to define the strategy in clinical formulation development.

Kuentz M.

AAPS J. 2008 Sep;10(3):473-9. doi: 10.1208/s12248-008-9054-3. Epub 2008 Aug 27. Review. Erratum in: AAPS J. 2009 Mar;11(1):32.

PMID:
18751901
[PubMed - indexed for MEDLINE]
Free PMC Article

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