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Items: 1 to 20 of 95

1.

Process map proposal for the validation of genomic biomarkers.

Goodsaid F, Frueh F.

Pharmacogenomics. 2006 Jul;7(5):773-82. Review.

PMID:
16886901
2.

Integrated assessment of preclinical data: shifting high attrition rates to earlier phase drug development.

Korstanje C.

Curr Opin Investig Drugs. 2003 May;4(5):519-21. Review. No abstract available.

PMID:
12833643
3.
4.

Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays.

Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, Shah VP, Skelly JP, Swann PG, Weiner R.

Pharm Res. 2007 Oct;24(10):1962-73. Epub 2007 Apr 26.

PMID:
17458684
5.

Development of guidance modules by the PDA to extend and/or eliminate periodic validation: a proposal to PDA Scientific Advisory Board.

Korczynski MS.

PDA J Pharm Sci Technol. 2003 Jul-Aug;57(4):245-8. No abstract available.

PMID:
14558698
6.

Transatlantic regulatory cooperation expanded.

Hughes B.

Nat Rev Drug Discov. 2007 Aug;6(8):589-90. No abstract available.

PMID:
17821826
7.

ICH topic: the draft ICH S7B step 2: note for guidance on safety pharmacology studies for human pharmaceuticals.

Bode G, Olejniczak K; ICH Expert Working Group.

Fundam Clin Pharmacol. 2002 Apr;16(2):105-18.

PMID:
12031063
8.

A prototypical process for creating evidentiary standards for biomarkers and diagnostics.

Altar CA, Amakye D, Bounos D, Bloom J, Clack G, Dean R, Devanarayan V, Fu D, Furlong S, Hinman L, Girman C, Lathia C, Lesko L, Madani S, Mayne J, Meyer J, Raunig D, Sager P, Williams SA, Wong P, Zerba K.

Clin Pharmacol Ther. 2008 Feb;83(2):368-71. Epub 2007 Dec 19.

PMID:
18091762
9.

The application of ICH S6 to the preclinical safety evaluation of plasma derivative therapeutic products.

Lewis RM, Cavagnaro J.

Biologicals. 2010 Jul;38(4):494-500. doi: 10.1016/j.biologicals.2010.03.001. Epub 2010 Apr 1.

PMID:
20359910
10.

A multistep validation process of biomarkers for preclinical drug development.

Freeman WM, Bixler GV, Brucklacher RM, Lin CM, Patel KM, VanGuilder HD, LaNoue KF, Kimball SR, Barber AJ, Antonetti DA, Gardner TW, Bronson SK.

Pharmacogenomics J. 2010 Oct;10(5):385-95. doi: 10.1038/tpj.2009.60. Epub 2009 Dec 8.

PMID:
19997081
11.

Improving drug manufacturing with process analytical technology.

Rodrigues LO, Alves TP, Cardoso JP, Menezes JC.

IDrugs. 2006 Jan;9(1):44-8.

PMID:
16374733
12.

FDA pharmaceutical quality oversight.

Yu LX, Woodcock J.

Int J Pharm. 2015 Aug 1;491(1-2):2-7. doi: 10.1016/j.ijpharm.2015.05.066. Epub 2015 May 29. Review.

PMID:
26027494
13.

AAPS-FDA workshop white paper: microdialysis principles, application and regulatory perspectives.

Chaurasia CS, Müller M, Bashaw ED, Benfeldt E, Bolinder J, Bullock R, Bungay PM, DeLange EC, Derendorf H, Elmquist WF, Hammarlund-Udenaes M, Joukhadar C, Kellogg DL Jr, Lunte CE, Nordstrom CH, Rollema H, Sawchuk RJ, Cheung BW, Shah VP, Stahle L, Ungerstedt U, Welty DF, Yeo H.

Pharm Res. 2007 May;24(5):1014-25. Epub 2007 Mar 27.

PMID:
17458685
14.

Pharmaceutical quality assessment.

Florence AT.

Int J Pharm. 2015 Aug 1;491(1-2):1. doi: 10.1016/j.ijpharm.2015.06.003. Epub 2015 Jun 6. No abstract available.

PMID:
26054801
15.
16.

Implementing the U.S. FDA guidance on pharmacogenomic data submissions.

Goodsaid F, Frueh FW.

Environ Mol Mutagen. 2007 Jun;48(5):354-8.

PMID:
17567848
17.
19.

An industry commentary on regulatory issues--microbiology.

Moldenhauer JE.

PDA J Pharm Sci Technol. 2002 Mar-Apr;56(2):60-4. No abstract available.

PMID:
11977405
20.

The applications of biomarkers in early clinical drug development to improve decision-making processes.

Kuhlmann J.

Ernst Schering Res Found Workshop. 2007;(59):29-45. Review.

PMID:
17117713

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