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Author: William Nowatzke, Eric Woolf
Keywords: Stability,biological samples,test article,bioanalytical,ligand binding assay,chromatographic assay Summary: Characterization of the stability of analytes in biological Stability , biological samples , test article , bio- ization of stability be the exact formulation administered to
The AAPS Journal; Vol. 9 Number 2, Jun 2007;Published Date:05/31/2007; DOI: 10.1208/aapsj0902013
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Author: Christina Avanti, Jean-Pierre Amorij, Dewi Setyaningsih, Andrea Hawe, Wim Jiskoot, Jan Visser, Alexej Kedrov, Arnold J. M. Driessen, Wouter L. J. Hinrichs, Henderik W. Frijlink
Keywords: citrate buffer,divalent metal ions,improved stability,oxytocin Summary: metal ions on the stability of aqueous oxytocin solutions was determined
did not increase stability, nor did the addition of
However, the stability of aqueous oxytocin in aqueous formulations
The AAPS Journal; Vol. 13 Number 2, Jun 2011;Published Date:05/31/2011; DOI: 10.1208/s12248-011-9268-7
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Author: Jarrod W. Collier, Rakhi B. Shah, Abhay Gupta, Vilayat Sayeed, Muhammad J. Habib, Mansoor A. Khan
Keywords: excipients,formulation,levothyroxine sodium pentahydrate,moisture sorption,stability Summary: Stability of formulations over shelf-life is critical for having a quality product. degradation of the active pharmaceutical ingredient (API), affecting potency and/or stability. purpose was to investigate the influence of processing and formulation factors on stability of
AAPS PharmSciTech; Vol. 11 Number 2, Jun 2010;Published Date:05/31/2010; DOI: 10.1208/s12249-010-9434-8
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Author: Michael James Wilson Johnston, Grant Frahm, Xuguang Li, Yves Durocher, Mary Alice Hefford
Keywords: circular dichroism,differential scanning calorimetry,glycosylation,interferon Summary: Purpose Thermal stability is considered an indication of
resulted in improved thermally stability when assessed with far
protein fold and conformational stability.
Pharmaceutical Research; Vol. 28 Number 7, Jul 2011;Published Date:06/30/2011; DOI: 10.1007/s11095-011-0402-0
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Author: Matthew D. Burke, Xiaorong He, Chris Cook, Greg A. Petrov, Susan Long, Mark D. Coffin
Keywords: DPP-IV,drug layered pellets,hydrolysis,moisture barrier,stability Summary: on accelerated stability to determine the lead approach and critical quality attributes. yielded a unique stability enhancement. The stability was highly dependent on the final tablet water content and could be further improved b
AAPS PharmSciTech; Vol. 14 Number 1, Mar 2013;Published Date:02/28/2013; DOI: 10.1208/s12249-012-9911-3
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Author: Kenneth Craig Waterman
Keywords: accelerated aging,QbD,shelf life,stability Summary: of the Accelerated Stability Assessment Program (ASAP) to Quality by Design (QbD) for Drug Product of chemical stability limited shelf life (expiry) than previously possible. this Accelerated Stability Assessment Program (ASAP) enables the coupling of product attributes (e.
AAPS PharmSciTech; Vol. 12 Number 3, Sep 2011;Published Date:08/31/2011; DOI: 10.1208/s12249-011-9657-3
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Author: Wei Wang, Drew N. Kelner
Keywords: clotting,stability,SEC-HPLC, SDS-PAGE,UV Summary: Aqueous stability samples of full-length rFVIII at different
examine the stability of FVIII in solution. clude the evaluation of the stability of reconstituted FVIII
Pharmaceutical Research; Vol. 20 Number 4, Apr 2003;Published Date:03/31/2003; DOI: 10.1023/A:1023271405005
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Author: E. D. Breen, J. G. Curley, D. E. Overcashier, C. C. Hsu, S. J. Shire
Keywords: protein stability,glass transition temperature,modulated DSC,aggregation,Asp isomerization Summary: thus, decreased stability (1) creasing stability (2) transition temperature (T ) on the stability of a high concentration,
Pharmaceutical Research; Vol. 18 Number 9, Sep 2001;Published Date:08/31/2001; DOI: 10.1023/A:1013054431517
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