Results 151 to 160 of about 440,585 (179)

Quality by Design and Analytical Quality by Design for Pharmaceutical Development

Quality Target Product Profile (QTPP) is a concept that describes all the quality attributes (QA) of the product that can be optimized during the product development. Quality Control (QC) allows to assess the quality of the final product by means of the monitoring of the QAs and thus it is a key factor in pharmaceutical and biopharmaceutical ...
S. Furlanetto, S. Orlandini, B. Pasquini, R. Gotti, A. Guiraldelli   +4 more
openaire   +1 more source

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
openaire   +1 more source

Simultaneous Estimation of Crotamiton and Hydrocortisone by RP-UPLC using Green Analytical Principles embedded Analytical Quality by Design (AQbD) Method

Microchemical journal (Print), 2022
K. Kannaiah, Abimanyu Sugumaran, Hemanth Kumar Chanduluru   +2 more
semanticscholar   +1 more source

Analytical Quality by Design and Quality Control of drugs: from Quality Target Product Profile to the Analytical Target Profile

2023
Quality Control (QC) plays a pivotal role in the pharmaceutical and biopharmaceutical development, as it is essential for assessing product's quality, safety and efficacy. It involves a series of analytical procedures designed and validated to inspect and monitor the product’s quality attributes.
S. Furlanetto, S. Orlandini, G. Pieraccini, R. Gotti, G. Massolini, C. Temporini, F. Luciani, F. Marino, A. Ascione, A. Guiraldelli, N. Rautela   +10 more
openaire   +1 more source

Analytical Quality by Design in Stress Testing or Stability - Indicating Method

, 2021
A. Vyas, Nilam M. Visana, Ajay Patel, Ashok B. Patel, N. Patel, Sunny Shah   +5 more
semanticscholar   +1 more source

Pitfalls and Opportunities in the Execution of Quality by Design in Analytical Sciences

Current Pharmaceutical Analysis, 2023
Pintu Prajapati, Prashant Kumar Chaturvedi, Shruti Chopra   +2 more
exaly  

Shaping Quality Control of Biopharmaceuticals with Analytical Quality by Design

In the pharmaceutical field, quality control is a fundamental step to ensure the safety and efficacy of drugs. Quality control is based on reliable analytical procedures (APs) that can be developed according to the principles of Analytical Quality by Design (AQbD).
S. Furlanetto, S. Orlandini, V. Ghizzani, L. Floris, B. Pasquini, R. Gotti, F. Luciani, G. Massolini   +7 more
openaire   +1 more source

Analytical Lifecycle Management (ALM) and Analytical Quality by Design (AQbD) for analytical procedure development of related substances in tenofovir alafenamide fumarate tablets

Journal of Pharmaceutical and Biomedical Analysis, 2022
Fuli Zhang, Haoxiang Wu
exaly  

Recent applications of Analytical Quality-by-Design methodology for chromatographic analysis: A review

Chemometrics and Intelligent Laboratory Systems
X. Doan, Hue Minh Thi Nguyen, Vu Dang Hoang   +2 more
semanticscholar   +1 more source

Development of an analytical method for the determination of pimavanserin and its impurities applying analytical quality by design principles as a risk-based strategy

Journal of Pharmaceutical and Biomedical Analysis, 2021
Sandra Babic, Mislav Runje
exaly