Results 121 to 130 of about 325 (160)

Phytochemical Characterization of <i>Pouteria guianensis</i>: Optimized Flavonoid Extraction and HPLC Method Validation. [PDF]

open access: yesACS Omega
de Matos RC   +5 more
europepmc   +1 more source

Development of a buccal in vitro permeation method – exploring aQbD implementation

International Journal of Pharmaceutics, 2023
The buccal mucosa is arising within the pharmaceutical landscape as an attractive option for local and systemic drug delivery, mostly due to its high vascularization, inherent permeability and robustness. Still, one of the major challenges in bringing oromucosal preparations to market remains the accurate evaluation of permeability. During pre-clinical
Ariana Sena   +6 more
openaire   +2 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 ...
Sant Kumar Verma
exaly   +2 more sources

Leveraging AQbD Principles for Development of Challenging Drug Substance Stability-Indicating Methods

Organic Process Research and Development, 2021
Drug substance stability-indicating methods (SIMs) must undergo a litany of optimization and robustness stresses to ensure that the methods can be successfully validated, transferred, and routinely...
Elizabeth M Yuill   +2 more
exaly   +2 more sources

aQbD as a platform for IVRT method development – A regulatory oriented approach

International Journal of Pharmaceutics, 2019
The EMA draft guideline on quality and equivalence of topical products and the FDA non-binding product specific guidances release has encouraged the establishment of a regulatory background for in vitro release testing (IVRT). Herein, a novel framework applicable to the development of a discriminatory IVRT method is described, according to analytical ...
Margarida Miranda   +3 more
openaire   +2 more sources

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