Results 11 to 20 of about 352,913 (253)
Background Analytical quality by design is a proactive, holistic, and data-driven approach to quality that emphasizes risk assessment and management. This can lead to more robust and reliable methods than traditional approaches.
Sarvesh Patil +3 more
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The article deals with the development of an analytical method based on AQbD and GAC for the simultaneous determination of Metronidazole (MET), Lidocaine (LID) and Miconazole (MIC) in oval dosage form using RP-HPLC.
Viswanathan Sukumar +2 more
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Throughout the 20th century, the notion of ‘quality’ underwent major changes. The concept of ‘Quality by Testing’, i.e. evaluating the quality of a product by testing it for some pre-defined parameters after completing the manufacturing process, started to be replaced by the enhanced approach of Quality by Design (QbD).
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HPLC method development for fampridine using Analytical Quality by Design approach
Offering a systematic and multivariate analysis of the analytical procedure, development and validation of HPLC methods using Quality by Design approach are in the limelight of current research trends.
Kovács Béla +6 more
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Background The development of chromatographic method and the validation of a sensitive, simple, efficient, and reversed-phase high-performance liquid chromatography (RP-HPLC) approach were adopted for the drug flurbiprofen (FBP) in nanoparticles ...
Shilpa R. Mandpe +2 more
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Analytical Procedure Validation and the Quality by Design Paradigm [PDF]
Since the adoption of the ICH Q8 document concerning the development of pharmaceutical processes following a quality by design (QbD) approach, there have been many discussions on the opportunity for analytical procedure developments to follow a similar approach.
Rozet, Eric +5 more
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Background A combination of pioglitazone hydrochloride with teneligliptin hydrobromide hydrate is used to treat type-2 diabetes. Several chromatographic techniques have been described in the literature for determination of each of these medications ...
Pintu Prajapati +3 more
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Green analytical procedures replace harmful organic modifiers with green solvents without affecting chromatographic performance, enabling industries and research laboratories to develop green analytical methods.
Naveenarani Dharuman +2 more
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A UPLC-MS method for the estimation of atazanavir sulfate was developed using the “analytical quality by design” approach. The critical chromatographic quality attributes identified were retention time, theoretical plates and peak tailing.
Saha Chandni +2 more
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Approach of analytical quality by design and regulatory need
This paper gives idea about the Pharmaceutical Quality by Design (QbD) and describes use of Quality by Design to ensure quality of Pharmaceuticals. Quality cannot be tested into products but quality should be built in by design. The concept of QbD can be extended to analytical methods.
Asmita Mahapatra, S. N. Meyyanathan
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