Results 31 to 40 of about 325 (160)
Development of a Stability-Indicating Analytical Method for Determination of Venetoclax Using AQbD Principles [PDF]
ACS Omega, 2020 Venetoclax is an emerging drug for the treatment of various types of blood cancers. It was first approved in 2016 for the treatment of relapsed and refractory chronic lymphocytic leukemia. Later, the indications expanded, and multiple research as well as clinical studies are still conducted involving venetoclax.
Nina Žigart, Zdenko Časar
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Molecules, 2023 The analytical quality by design (AQbD) approach is utilized for developing and validating the simple, sensitive, cost-effective reverse-phase high performance liquid chromatographic method for the estimation of xanthohumol (XH) in bulk and ...
Vancha Harish +11 more
doaj +1 more source
Analytical Quality by Design (AQbD) Approach to the Development of In Vitro Release Test for Topical Hydrogel [PDF]
Pharmaceutics, 2022 The aim of our study was to adapt the analytical quality by design (AQbD) approach to design an effective in vitro release test method using USP apparatus IV with a semi-solid adapter (SSA) for diclofenac sodium hydrogel. The analytical target profile (ATP) of the in vitro release test and ultra-high-performance liquid chromatography were defined; the ...
Réka Szoleczky +6 more
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Quality by Design‐Based Development of a Robust LC Method for Simultaneous Estimation of Process‐ and Degradation‐Related Impurities in Rifapentine Drug Product for the Treatment of Active and Latent Tuberculosis [PDF]
Biomed ChromatogrABSTRACT A precise, robust, and stability‐indicating liquid chromatographic (LC) method coupled with a photodiode array (PDA) detector was developed and validated for the quantitative estimation of rifapentine, an essential therapeutic agent for both active and latent tuberculosis (TB).
Korikana S +5 more
europepmc +2 more sources
Journal of Separation Science, Volume 46, Issue 24, December 2023., 2023 Analytical Quality by Design principles using the design of experiments were applied for the development of a capillary electrophoresis method for the determination of enantiomeric purity and chemically related impurities of tamsulosin. From initial scouting experiments, a dual cyclodextrin (CD) system composed of sulfated β‐CD and carboxymethyl‐α‐CD ...
Adriana Modroiu +3 more
wiley +1 more source
Pharmaceutics, 2020 A key principle of developing a new medicine is that quality should be built in, with a thorough understanding of the product and the manufacturing process supported by appropriate process controls. Quality by design principles that have been established
Juan Almeida +5 more
doaj +1 more source
ELECTROPHORESIS, Volume 44, Issue 17-18, Page 1279-1341, September 2023., 2023 Abstract This review is in support of the development of selective, precise, fast, and validated capillary electrophoresis (CE) methods. It follows up a similar article from 1998, Wätzig H, Degenhardt M, Kunkel A. “Strategies for capillary electrophoresis: method development and validation for pharmaceutical and biological applications,” pointing out ...
Finja Krebs +11 more
wiley +1 more source
Journal of Chemical Technology &Biotechnology, Volume 97, Issue 9, Page 2347-2364, September 2022., 2022 Abstract The transition to continuous biomanufacturing is considered the next step to reduce costs and improve process robustness in the biopharmaceutical industry, while also improving productivity and product quality. The platform production process for monoclonal antibodies (mAbs) is eligible for continuous processing to lower manufacturing costs ...
Mariana N São Pedro +3 more
wiley +1 more source
Sixteen capillary electrophoresis applications for viral vaccine analysis
ELECTROPHORESIS, Volume 43, Issue 9-10, Page 1068-1090, May 2022., 2022 Abstract A broad range of CE applications from our organization is reviewed to give a flavor of the use of CE within the field of vaccine analyses. Applicability of CE for viral vaccine characterization, and release and stability testing of seasonal influenza virosomal vaccines, universal subunit influenza vaccines, Sabin inactivated polio vaccines ...
Lars Geurink +6 more
wiley +1 more source
Application of AQbD to cIEF of Protein Biopharmaceuticals [PDF]
Biomedical Journal of Scientific & Technical Research, 2019 Protein biopharmaceuticals like monoclonal antibodies (mAbs), recombinant and therapeutic proteins are recently in widespread treated of various diseases including cancer, autoimmune disease, cardiovascular, hematology and so on...
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