Results 11 to 20 of about 62,955,482 (158)

A Practical Approach to Implementing ICH Q14: Tools for Analytical Quality by Design in Capillary Electrophoresis Method Development [PDF]

ELECTROPHORESIS, Volume 46, Issue 13-14, Page 933-953, July 2025.
ABSTRACT The ICH Q14 guideline introduces a structured framework for analytical method development based on Analytical Quality by Design (AQbD) principles, aiming to ensure robust, reliable, and fit‐for‐purpose methods throughout the product lifecycle.
Ewoud van Tricht, Cari E. Sänger ‐ van de Griend   +1 more
wiley   +3 more sources

Analytical Quality by Design‐Based Reverse‐Phase High‐Performance Liquid Chromatography Method Development for Biomarker: A Comprehensive Review of Quality Assessment and Analytical Trends [PDF]

Biomed Chromatogr
Biomarkers play a crucial role in disease diagnosis and therapeutic monitoring, necessitating the development of reliable and robust analytical methods.
Shubhangi B. Sutar, Sakshi B. Patil, Rachana Bhimanwar   +2 more
core   +2 more sources

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]

Biomedical Chromatography, Volume 40, Issue 5, May 2026.
ABSTRACT 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).
Siva Prasad Korikana, Sreenivasa Rao Battula, Naresh Konduru, Aravind Kurnool, Divya Kumar Vemuri, Venkata Lakshamana Sagar Dantinapalli   +5 more
wiley   +2 more sources

Systematic Development and Validation of a Thin-Layer Densitometric Bioanalytical Method for Estimation of Mangiferin Employing Analytical Quality by Design (AQbD) Approach [PDF]

Journal of Chromatographic Science, 2016
The present work aims at the systematic development of a simple, rapid and highly sensitive densitometry-based thin-layer chromatographic method for the quantification of mangiferin in bioanalytical samples. Initially, the quality target method profile was defined and critical analytical attributes (CAAs) earmarked, namely, retardation factor (Rf ...
Rajneet Kaur, Khurana, Satish, Rao, Sarwar, Beg, O P, Katare, Bhupinder, Singh   +4 more
openaire   +3 more sources

Characterisation of Antisense Oligonucleotides by Ion‐Pair Reversed‐Phase UHPLC‐HRMS: Method development using Design of Experiments [PDF]

Journal of Mass Spectrometry, Volume 61, Issue 4, April 2026.
ABSTRACT The quality control of therapeutic antisense oligonucleotides (ASOs) poses significant analytical challenges due to the complexity of their synthesis and degradation processes and the need to ensure the safety and efficacy of active pharmaceutical ingredients (APIs).
Antonio Triolo, Fabiana Tavani, Prisca Barnini, Sandra Furlanetto, Serena Orlandini   +4 more
wiley   +2 more sources

AQbD-Based UPLC-ELSD Method for Quantifying Medium Chain Triglycerides in Labrafac™ WL 1349 for Nanoemulsion Applications [PDF]

Molecules
In response to recent regulatory guidelines, including ICH (International Council for Harmonisation) Q2 (R2) and Q14, we developed a UPLC-ELSD method to quantify Medium-Chain Triglycerides (MCTs) in Labrafac™ WL 1349 for nanoemulsion applications ...
Dalibor Jeremic, Viktoria Marko, Philippe Caisse, Alessio Gaggero, Jesús Alberto Afonso Urich, Carolin Tetyczka   +5 more
core   +2 more sources

Important Aspects of the Design of Experiments and Data Treatment in the Analytical Quality by Design Framework for Chromatographic Method Development [PDF]

Molecules
In the analytical quality by design (AQbD) framework, the design of experiments (DOE) plays a very important role, as it provides information about how experimental input variables influence critical method attributes.
Márcia C. Breitkreitz, Bianca F. G. Passerine   +1 more
core   +2 more sources

Quality by Design: Approach to Analytical Method Validation [PDF]

, 2022
A pharmaceutical industry is highly regulated by a quality policy in its management. The principles of Quality by Design (QbD) must be applied to ensure the development of pragmatic and systematic methods while managing the risks associated with ...
Chaerunisaa, Anis Yohana, Arifka, Mia, Pratama, Reza, Dewi, Mayang Kusuma   +3 more
core   +1 more source

Approach of analytical quality by design and regulatory need [PDF]

, 2022
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
Mahapatra, Asmita, Meyyanathan, S. N.
core   +1 more source

Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics [PDF]

, 2015
Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach.
Kalva Bhadraya, Ramalingam Peraman, Yiragamreddy Padmanabha Reddy   +2 more
core   +1 more source