DOI: 10.1002/jps.20466. A Process Analytical Technology approach to near-infrared process control of pharmaceutical powder blending: Part II: Qualitative near-infrared models for prediction of blend homogeneity

A Process Analytical Technology approach to near-infrared process control of pharmaceutical powder blending: Part II: Qualitative near-infrared models for prediction of blend homogeneity

10.1002/jps.20466

Crossref journal-article

Elsevier BV

Journal of Pharmaceutical Sciences (78)

Bibliography

El-Hagrasy, A. S., Delgado-Lopez, M., & Drennen, J. K. (2006). A Process Analytical Technology approach to near-infrared process control of pharmaceutical powder blending: Part II: Qualitative near-infrared models for prediction of blend homogeneity. Journal of Pharmaceutical Sciences, 95(2), 407â421.

Authors 3

Arwa S. El-Hagrasy (first)
Miriam Delgado-Lopez (additional)
James K. Drennen (additional)

References 23 Referenced 84

{'key': '10.1002/jps.20466_bb0010', 'series-title': 'Guidance for industry PAT—A framework for innovative pharmaceutical development, manufacturing, and quality assurance', 'author': 'FDA', 'year': '2004'} / Guidance for industry PAT—A framework for innovative pharmaceutical development, manufacturing, and quality assurance by FDA (2004)
{'key': '10.1002/jps.20466_bb0015', 'series-title': 'PDA Technical Report No 25 51:', 'first-page': 'S1', 'article-title': 'Blend uniformity analysis: Validation and in-process testing', 'author': 'Berman', 'year': '1997'} / PDA Technical Report No 25 51: / Blend uniformity analysis: Validation and in-process testing by Berman (1997)
{'key': '10.1002/jps.20466_bb0020', 'first-page': '20', 'article-title': 'Errors associated with the thief probe for bulk powder sampling', 'volume': '11', 'author': 'Harwood', 'year': '1977', 'journal-title': 'J Powder Bulk Solids Technol'} / J Powder Bulk Solids Technol / Errors associated with the thief probe for bulk powder sampling by Harwood (1977)
10.3109/03639049509063017 / Drug Dev Ind Pharm / Blend uniformity and unit dose sampling by Berman (1995)
10.3109/03639049609065948 / Drug Dev Ind Pharm / Unit Dose sampling: A tale of two thieves by Berman (1996)
10.3109/03639049609065937 / Drug Dev Ind Pharm / An evaluation of a unit-does compacting sample thief and a discussion of content uniformity testing and blending validation issues by Chang (1996)
10.3109/10837459809028474 / Pharm Dev Technol / Comparison of the performance of two sample thieves for the determination of the content uniformity of a powder blend by Garcia (1998)
{'key': '10.1002/jps.20466_bb0045', 'first-page': '92', 'article-title': 'An improved powder-sampling tool', 'volume': '23', 'author': 'Muzzio', 'year': '1999', 'journal-title': 'Pharm Technol'} / Pharm Technol / An improved powder-sampling tool by Muzzio (1999)
10.1016/0731-7085(96)01739-6 / J Pharm Biomed Anal / Near-infrared spectroscopic characterization of pharmaceutical powder blends by Wargo (1996)
10.1021/ac950964m / Anal Chem / On-line monitoring of powder blend homogeneity by near-infrared spectroscopy by Sekulic (1996)
10.1002/jps.1082 / J Pharm Sci / Near-infrared spectroscopy and imaging for the monitoring of powder blend homogeneity by El-Hagrasy (2001)
10.1081/DDC-100107329 / Drug Dev Ind Pharm / Modeling of powder blending using on-line near-infrared measurements by Ufret (2001)
10.1016/S0032-5910(01)00456-9 / Powder Technol / Quantitative in-line monitoring of powder blending by near-infrared reflection spectroscopy by Berntsson (2002)
10.1208/pt030324 / AAPS Pharm Sci Tech / Blend uniformity analysis using stream sampling and near infrared spectroscopy by Popo (2002)
{'key': '10.1002/jps.20466_bb0080', 'first-page': '467', 'article-title': 'An examination of dynamic and static near infrared measurements of pharmaceutical blends', 'author': 'Lowery', 'year': '1999'} / An examination of dynamic and static near infrared measurements of pharmaceutical blends by Lowery (1999)
10.1002/jps.20467 / J Pharm Sci / A process analytical technology approach to near-infrared process control of pharmaceutical powder blending. Part I: D-optimal design for characterization of powder mixing and preliminary spectral data evaluation by El-Hagrasy (2006)
10.1021/ac00177a012 / Anal Chem / Raw materials testing using soft independent modeling of class analogy analysis of near-infrared reflectance spectra by Gemperline (1989)
10.1366/0003702884429562 / Appl Spectrosc / Detection of subpopulations in near-infrared reflectance analysis by Lodder (1988)
10.1002/jps.20465 / J Pharm Sci / A process analytical technology approach to near-infrared process control of pharmaceutical powder blending. Part III: Quantitative near-infrared calibration for prediction of blend homogeneity and characterization of powder mixing kinetics by El-Hagrasy (2006)
{'key': '10.1002/jps.20466_bb0105', 'series-title': 'A “noise” in pharmaceutical analysis: Near-infrared outside/inside space evaluation', 'first-page': '248', 'author': 'Drennen', 'year': '1990'} / A “noise” in pharmaceutical analysis: Near-infrared outside/inside space evaluation by Drennen (1990)
10.1016/B978-1-4831-0092-0.50010-8 / Adv Near-Infrared Meas / Pharmaceutical applications of near-infrared spectrometry by Drennen (1993)
10.1007/BF00323062 / Fresnius J Anal Chem / Monitoring powder blending by NIR spectroscopy by Sánchez (1995)
10.1208/pt030317 / AAPS Pharm Sci Tech / Near-infrared spectral imaging for quality assurance of pharmaceutical products: Analysis of tablets to assess powder blend homogeneity by Lyon (2002)

Dates

Type	When
Created	19 years, 8 months ago (Dec. 27, 2005, 3:46 p.m.)
Deposited	6 years, 4 months ago (April 12, 2019, 9:51 a.m.)
Indexed	11 months, 3 weeks ago (Sept. 12, 2024, 7:36 p.m.)
Issued	19 years, 7 months ago (Feb. 1, 2006)
Published	19 years, 7 months ago (Feb. 1, 2006)
Published Print	19 years, 7 months ago (Feb. 1, 2006)

Funders 0

None

BibTeX

@article{El_Hagrasy_2006, title={A Process Analytical Technology approach to near-infrared process control of pharmaceutical powder blending: Part II: Qualitative near-infrared models for prediction of blend homogeneity}, volume={95}, ISSN={0022-3549}, url={http://dx.doi.org/10.1002/jps.20466}, DOI={10.1002/jps.20466}, number={2}, journal={Journal of Pharmaceutical Sciences}, publisher={Elsevier BV}, author={El-Hagrasy, Arwa S. and Delgado-Lopez, Miriam and Drennen, James K.}, year={2006}, month=feb, pages={407–421} }

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