Research ArticleTechnology/Application
Validation of a Spectral Method for Quantitative Measurement of Color in Protein Drug Solutions
Jian Yin, Trevor E. Swartz, Jian Zhang, Thomas W. Patapoff, Bartolo Chen, Joseph Marhoul, Norman Shih, Bruce Kabakoff and Kimia Rahimi
PDA Journal of Pharmaceutical Science and Technology July 2016, 70 (4) 382-391; DOI: https://doi.org/10.5731/pdajpst.2016.006494
Jian Yin
1Early Stage Pharmaceutical Development Department,
Trevor E. Swartz
1Early Stage Pharmaceutical Development Department,
Jian Zhang
2Analytical Development and Quality Control Department, and
Thomas W. Patapoff
1Early Stage Pharmaceutical Development Department,
Bartolo Chen
2Analytical Development and Quality Control Department, and
Joseph Marhoul
3Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA
Norman Shih
1Early Stage Pharmaceutical Development Department,
Bruce Kabakoff
1Early Stage Pharmaceutical Development Department,
Kimia Rahimi
2Analytical Development and Quality Control Department, and

References
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- 2.↵European Pharmacopoeia Commission. European Pharmacopoeia, Version 8; Council of Europe: Strasbourg, France, 2014; p v.
- 3.↵
- Swartz T. E,
- Yin J.,
- Patapoff T.,
- Horst T.,
- Skieresz S. M.,
- Leggett G.,
- Morgan C. J.,
- Rahimi K.,
- Marhoul J.,
- Kabakoff B.
- 4.↵ICH Harmonized Tripartite Guideline: Validation of Analytical Procedures: Text and Methadology Q2(R1). In International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, version 4, 1994.
- 5.↵ASTM International. ASTM E308-08: Standard Practice for Computing the Colors of Objects by Using the CIE System, 2008.
- 6.↵
- 7.↵
- Shevell S. K.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 4
July/August 2016
Validation of a Spectral Method for Quantitative Measurement of Color in Protein Drug Solutions
Jian Yin, Trevor E. Swartz, Jian Zhang, Thomas W. Patapoff, Bartolo Chen, Joseph Marhoul, Norman Shih, Bruce Kabakoff, Kimia Rahimi
PDA Journal of Pharmaceutical Science and Technology Jul 2016, 70 (4) 382-391; DOI: 10.5731/pdajpst.2016.006494
Validation of a Spectral Method for Quantitative Measurement of Color in Protein Drug Solutions
Jian Yin, Trevor E. Swartz, Jian Zhang, Thomas W. Patapoff, Bartolo Chen, Joseph Marhoul, Norman Shih, Bruce Kabakoff, Kimia Rahimi
PDA Journal of Pharmaceutical Science and Technology Jul 2016, 70 (4) 382-391; DOI: 10.5731/pdajpst.2016.006494
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