Publications by authors named "Andre Raw"

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Nitrosamine mitigation: NDMA impurity formation and its inhibition in metformin hydrochloride tablets.
Diaa Shakleya, Alaadin Alayoubi, Dustin Brown, Alaa Mokbel, Nicolas Abrigo, Andre Raw

Int J Pharm· December 2024

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Optimizing the detection of N-nitrosamine mutagenicity in the Ames test.
Robert H Heflich, Michelle E Bishop, Roberta A Mittelstaedt, Jian Yan, Sharon K Guerrero, Andre S Raw

Regul Toxicol Pharmacol· November 2024

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Antioxidants had No Effects on the In-Vitro Permeability of BCS III Model Drug Substances.
Dongmei Lu, Bhagwant Rege, Andre Raw, Jingyue Yang, Khondoker Alam

J Pharm Sci· September 2024

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Effect of Antioxidants in Medicinal Products on Intestinal Drug Transporters.
Chetan P Kulkarni, Jia Yang, Megan L Koleske, Giovanni Lara, Khondoker Alam, Andre Raw

Pharmaceutics· May 2024

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Bumetanide as a Model NDSRI Substrate: N-nitrosobumetanide Impurity Formation and its Inhibition in Bumetanide Tablets.
Diaa Shakleya, Bethel Asmelash, Alaadin Alayoubi, Nicolas Abrigo, Adil Mohammad, Andre Raw

J Pharm Sci· December 2023

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FDA's new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications.
Lawrence X Yu, Andre Raw, Larisa Wu, Christina Capacci-Daniel, Ying Zhang

Int J Pharm X· December 2019

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Physicochemical Characterization of Iron Carbohydrate Colloid Drug Products.
Peng Zou, Katherine Tyner, Andre Raw, Sau Lee

AAPS J· September 2017

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Building parity between brand and generic peptide products: Regulatory and scientific considerations for quality of synthetic peptides.
Larisa C Wu, Fu Chen, Sau L Lee, Andre Raw, Lawrence X Yu

Int J Pharm· February 2017

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Erratum to: Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products.
Rong-Kun Chang, Andre Raw, Robert Lionberger, Lawrence Yu

AAPS J· November 2015

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Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.
Lawrence X Yu, Jeffrey Baker, Susan C Berlam, Ashley Boam, E J Brandreth, Andre Raw

AAPS J· July 2015

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Current challenges in bioequivalence, quality, and novel assessment technologies for topical products.
Avraham Yacobi, Vinod P Shah, Edward D Bashaw, Eva Benfeldt, Barbara Davit, Andre Raw

Pharm Res· April 2014

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Pharmaceutical characterization and thermodynamic stability assessment of a colloidal iron drug product: iron sucrose.
Rakhi B Shah, Yongsheng Yang, Mansoor A Khan, Andre Raw, Lawrence X Yu

Int J Pharm· April 2014

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Generic development of topical dermatologic products, Part II: quality by design for topical semisolid products.
Rong-Kun Chang, Andre Raw, Robert Lionberger, Lawrence Yu

AAPS J· July 2013

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Scientific considerations in the review and approval of generic enoxaparin in the United States.
Sau Lee, Andre Raw, Lawrence Yu, Robert Lionberger, Naiqi Ya

Nat Biotechnol· March 2013

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Generic development of topical dermatologic products: formulation development, process development, and testing of topical dermatologic products.
Rong-Kun Chang, Andre Raw, Robert Lionberger, Lawrence Yu

AAPS J· January 2013

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Physicochemical characterization of complex drug substances: evaluation of structural similarities and differences of protamine sulfate from various sources.
David Awotwe-Otoo, Cyrus Agarabi, David Keire, Sau Lee, Andre Raw

AAPS J· September 2012

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Use of partial AUC to demonstrate bioequivalence of Zolpidem Tartrate Extended Release formulations.
Robert A Lionberger, Andre S Raw, Stephanie H Kim, Xinyuan Zhang, Lawrence X Yu

Pharm Res· April 2012

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Crystallinity evaluation of tacrolimus solid dispersions by chemometric analysis.
Ahmed S Zidan, Ziyaur Rahman, Vilayat Sayeed, Andre Raw, Lawrence Yu

Int J Pharm· February 2012

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Pharmaceutical equivalence by design for generic drugs: modified-release products.
André Sirota Raw, Robert Lionberger, Lawrence X Yu

Pharm Res· July 2011

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Scientific considerations for generic synthetic salmon calcitonin nasal spray products.
Sau L Lee, Lawrence X Yu, Bing Cai, Gibbes R Johnsons, Amy S Rosenberg, Andre S Raw

AAPS J· March 2011

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Thermodynamic stability assessment of a colloidal iron drug product: sodium ferric gluconate.
Yongsheng Yang, Rakhi B Shah, Patrick J Faustino, Andre Raw, Lawrence X Yu

J Pharm Sci· January 2010

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Generic omeprazole delayed-release capsules: in vitro performance evaluations.
Terry Moore, Anjanette Smith, Wei Ye, Duckhee Y Toler, Benjamin J Westenberger, Andre Raw

Drug Dev Ind Pharm· August 2009

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Quality by design: concepts for ANDAs.
Robert A Lionberger, Sau Lawrence Lee, Laiming Lee, Andre Raw, Lawrence X Yu

AAPS J· June 2008

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Pharmaceutical impurities: analytical, toxicological and regulatory perspectives.
Arup K Basak, Andre S Raw, Lawrence X Yu

Adv Drug Deliv Rev· January 2007

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Pharmaceutical impurities: regulatory perspective for Abbreviated New Drug Applications.
Arup K Basak, Andre S Raw, Ali H Al Hakim, Scott Furness, Nashed I Samaan

Adv Drug Deliv Rev· January 2007

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