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Text: stability
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Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples
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
A New Strategy to Stabilize Oxytocin in Aqueous Solutions: I. The Effects of Divalent Metal Ions and Citrate Buffer
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
Influence of Formulation and Processing Factors on Stability of Levothyroxine Sodium Pentahydrate
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
O-Linked Glycosylation Leads to Decreased Thermal Stability of Interferon Alpha 2b as Measured by Two Orthogonal Techniques
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
Stability Enhancement of Drug Layered Pellets in a Fixed Dose Combination Tablet
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
The Application of the Accelerated Stability Assessment Program (ASAP) to Quality by Design (QbD) for Drug Product Stability
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
Correlation of rFVIII Inactivation with Aggregation in Solution
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
Effect of Moisture on the Stability of a Lyophilized Humanized Monoclonal Antibody Formulation
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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