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Journal of Biopharmaceutical Statistics Volume 25, 2015 - Issue 2: Recent Developments in Statistical Approaches for Chemistry and Manufacturing Control (CMC) and Quality-by-Design (QbD)
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Original Articles

Analytical Procedure Validation and the Quality by Design Paradigm

Eric RozetArlenda S.A., Liège, BelgiumCorrespondence[email protected]
,
Pierre LebrunArlenda S.A., Liège, Belgium
,
Jean-François MichielsArlenda S.A., Liège, Belgium
,
Perceval SondagArlenda S.A., Liège, Belgium
,
Tara ScherderArlenda Inc., Flemington, New Jersey, USA
&
Bruno BoulangerArlenda S.A., Liège, Belgium
Pages 260-268 | Received 26 Sep 2014, Accepted 26 Sep 2014, Published online: 25 Feb 2015

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Shahd F. Al-Tarawneh, Eman Zmaily Dahmash, Hamad Alyami, Suha M. Abu-Doleh, Samer Al-Ali, Affiong Iyire & Rasha Abuthawabeh. (2022) Mechanistic modelling of targeted pulmonary delivery of dactinomycin iron oxide-loaded nanoparticles for lung cancer therapy. Pharmaceutical Development and Technology 27:10, pages 1057-1068.
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Articles from other publishers (15)

Mohana Krishnan Santhanam, Nalini Calamur Nagarajan, Poorna Basuri Ponraj & Mohamed Sameer Mohamed Hilurudeen. (2023) A Complete Roadmap of Analytical Quality by Design in Various Analytical Techniques. Current Pharmaceutical Analysis 19:3, pages 184-215.
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Maíra Ribeiro de Souza, Mariana Koetz, Renata Pereira Limberger & Amélia Teresinha Henriques. (2022) DoE‐assisted development and validation of a stability‐indicating HPLC‐DAD method for simultaneous determination of five cannabinoids in Cannabis sativa L. based on analytical quality by design (AQbD) concept . Phytochemical Analysis 33:7, pages 999-1017.
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Mahmoud M. Sebaiy, Sobhy M. El-Adl, Mohamed M. Baraka, Amira A. Hassan & Heba M. El-Sayed. (2022) Quality by design approach for development and validation of a RP-HPLC method for simultaneous estimation of xipamide and valsartan in human plasma. BMC Chemistry 16:1.
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Thierry Bastogne, Fanny Caputo, Adriele Prina-Mello, Sven Borgos & Muriel Barberi-Heyob. (2022) A state of the art in analytical quality-by-design and perspectives in characterization of nano-enabled medicinal products. Journal of Pharmaceutical and Biomedical Analysis 219, pages 114911.
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Emmanuel Orman, Anthony Assumang, James Oppong-Kyekyeku, Peter Jagri Onilimor, Paul Kweku Peprah, Joseph Kwasi Adu, Samuel Oppong Bekoe & Samuel Asare-Nkansah. (2022) Chromatographic method development for the simultaneous assay of pseudoephedrine hydrochloride and chlorphenamine maleate in oral dosage formulations. Scientific African 15, pages e01109.
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Sunitha Gurrala, Shiva Raj, Subrahmanyam CVS & Panikumar Durga Anumolu. (2022) Quality-by-Design Approach for Chromatographic Analysis of Metformin, Empagliflozin and Linagliptin. Journal of Chromatographic Science 60:1, pages 68-80.
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Elizabeth M. Yuill, Kevin M. Ileka, Thomas E. La Cruz, Jieming Li, Jonathan G. Shackman, Peter I. Tattersall & Jia Zang. (2021) Leveraging AQbD Principles for Development of Challenging Drug Substance Stability-Indicating Methods. Organic Process Research & Development 25:6, pages 1431-1439.
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Paul Faya, Perceval Sondag, Steven Novick, Dwaine Banton, John W. Seaman, Jr, James D. Stamey & Bruno Boulanger. (2020) The current state of Bayesian methods in nonclinical pharmaceutical statistics: Survey results and recommendations from the DIA / ASA‐BIOP Nonclinical Bayesian Working Group . Pharmaceutical Statistics 20:2, pages 245-255.
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Riccardo Deidda, Serena Orlandini, Philippe Hubert & Cédric Hubert. (2018) Risk-based approach for method development in pharmaceutical quality control context: A critical review. Journal of Pharmaceutical and Biomedical Analysis 161, pages 110-121.
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Fien De Leersnyder, Elisabeth Peeters, Hasna Djalabi, Valérie Vanhoorne, Bernd Van Snick, Ke Hong, Stephen Hammond, Angela Yang Liu, Eric Ziemons, Chris Vervaet & Thomas De Beer. (2018) Development and validation of an in-line NIR spectroscopic method for continuous blend potency determination in the feed frame of a tablet press. Journal of Pharmaceutical and Biomedical Analysis 151, pages 274-283.
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Yuanling Sun, Yanhui Wang, Jianbo Li, Chaofan Ding, Yanna Lin, Weiyan Sun & Chuannan Luo. (2017) An ultrasensitive chemiluminescence aptasensor for thrombin detection based on iron porphyrin catalyzing luminescence desorbed from chitosan modified magnetic oxide graphene composite. Talanta 174, pages 809-818.
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Lu Wang & Haibin Qu. (2016) Development and optimization of SPE-HPLC-UV/ELSD for simultaneous determination of nine bioactive components in Shenqi Fuzheng Injection based on Quality by Design principles. Analytical and Bioanalytical Chemistry 408:8, pages 2133-2145.
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Hanimi Reddy Bapatu, Ravi Kumar Maram, Woo Hyung Cho & Venkat Bhaskar Rao Pasagadugula. (2016) QbD Approach Method Development for Estimation of Dabigatran Etexilate along with Its Impurities and Identification of Degradants in Capsule Dosage Form. American Journal of Analytical Chemistry 07:06, pages 494-524.
Crossref
Perceval Sondag, Pierre Lebrun, Eric Rozet & Bruno Boulanger. 2016. Nonclinical Statistics for Pharmaceutical and Biotechnology Industries. Nonclinical Statistics for Pharmaceutical and Biotechnology Industries 415 432 .
John Peterson & Stan Altan. 2016. Nonclinical Statistics for Pharmaceutical and Biotechnology Industries. Nonclinical Statistics for Pharmaceutical and Biotechnology Industries 383 414 .

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