Results 161 to 170 of about 1,038 (200)

Polyclonal Antibody Therapeutics: Analytical Innovations and Regulatory Perspectives for Addressing Heterogeneity Challenges. [PDF]

Anal Chem
Kumar S, Tini A, Tengattini S, Rinaldi F, Calleri E, Massolini G, Temporini C.   +6 more
europepmc   +1 more source

Scale-Agnostic Models Based on Dimensionless Quality by Design as Pharmaceutical Development Accelerator. [PDF]

Pharmaceuticals (Basel)
Romero-Obon M, Sancho-Ochoa V, Rouaz-El-Hajoui K, Pérez-Lozano P, Suñé-Pou M, Suñé-Negre JM, García-Montoya E.   +6 more
europepmc   +1 more source

Artificial intelligence versus traditional approaches in multicomponent spectral analysis. [PDF]

Sci Rep
Fahmy NM, Obaydo RH, Lotfy HM.
europepmc   +1 more source

Assessment of volatile component stability in Guanxin Jieyu granules through gas chromatography in accordance with Q14 guidelines. [PDF]

Sci Rep
Chen L, Zhang T, Fang N, Wan H, He Y, Wan H.   +5 more
europepmc   +1 more source

Hydrolytic stress degradation study and concomitant HPTLC estimation of thioctic acid and biotin in their combined capsules: greenness, blueness and whiteness assessment. [PDF]

BMC Chem
El-Kafrawy DS, Abo-Gharam AH.
europepmc   +1 more source

DoE-assisted HPLC method development and validation of enzalutamide and repaglinide in rat plasma. [PDF]

Bioanalysis
Reddy GN, Jogvanshi A, Reddy DS, Chenkual L, Sonti R.   +4 more
europepmc   +1 more source

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Implementing Analytical Quality by Design (AQbD) Approach for Simultaneous Estimation of Tadalafil and Macitentan by RP-HPLC Method

Analytical Chemistry Letters, 2021
The principle motive behind this work is to develop robust, low cost, and regulatory flexible method for Tadalafil and Macitentan by RP-HPLC using Analytical Quality by Design principles.
Amitkumar J. Vyas, Dhruvanshi A. Gol, Ajay I. Patel, Ashok B. Patel, Nilesh K. Patel, Jayant R. Chavda, Arvind Lumbhani, Alpesh Chudasama   +7 more
semanticscholar   +4 more sources

A Review on Advancement in Analytical Quality by Design (AQbD)

Current Analytical Chemistry
Analytical Quality by Design (AQbD) represents a transformative methodology in pharmaceutical development, anchored in a systematic, risk-based, and data-driven framework. This approach optimizes analytical methods, fostering heightened product quality, efficient regulatory compliance, and informed decision ...
Ankit Kumar Singh, Yogita Vashitha, Ashita Jain, Ghanshyam Das Gupta, Sant Kumar Verma   +4 more
semanticscholar   +4 more sources

A platform analytical quality by design (AQbD) approach for multiple UHPLC-UV and UHPLC–MS methods development for protein analysis

Journal of Pharmaceutical and Biomedical Analysis, 2016
A platform analytical quality by design approach for methods development is presented in this paper. This approach is not limited just to method development following the same logical Analytical quality by design (AQbD) process, it is also exploited across a range of applications in methods development with commonality in equipment and procedures.
Jianmei, Kochling, Wei, Wu, Yimin, Hua, Qian, Guan, Juan, Castaneda-Merced   +4 more
semanticscholar   +5 more sources

Development and optimization of a stability-indicating chromatographic method for verapamil hydrochloride and its impurities in tablets using an analytical quality by design (AQbD) approach

Microchemical Journal, 2020
Abstract Development and optimization of analytical methods for quantifying verapamil hydrochloride in its twelve impurities is a challenge for analytical chemists and pharmacists. The aim of this paper was to apply the analytical quality by design (AQbD) and design of experiments (DoE) approaches in the development of a robust, low-cost, regulatory ...
Camila dos Santos Moreira, Felipe Rebello Lourenço   +1 more
semanticscholar   +4 more sources