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API Quality by Design Example from the Torcetrapib Manufacturing Process
The concept and application of quality by design (QbD) principles has been and will undoubtedly continue to be an evolving topic in the pharmaceutical industry. However, there are few and limited
Misunderstanding Design Space: a Robust Drug Product Control Strategy Is the Key to Quality Assurance
TLDR
It is suggested that Control Strategy is the most important QbD concept, and one that assures product quality for patients, and a focus by both regulators and manufacturers on the significance of Control Strategy could facilitate management of post approval changes to improve manufacturing processes and enhance product quality while also engendering regulatory harmonization.
Asymmetric catalysis in the pharmaceutical industry.
Chemical Development of MDL 103371: An N-Methyl-d-Aspartate-Type Glycine Receptor Antagonist for the Treatment of Stroke†
MDL 103371 is a N-methyl-d-aspartate (NMDA)-type glycine receptor antagonist for the potential treatment of stroke. Evaluation of five different synthetic routes, which included Stille, Suzuki, enol
A novel, efficient and general synthetic route to unsymmetrical triphenylene mesogens using palladium-catalysed cross-coupling reactions
A novel, clean and efficient route to unsymmetrical triphenylene mesogens has been developed using palladium-catalysed cross-coupling reactions involving arylboronic acids.
Establishing Patient Centric Specifications for Drug Substance and Drug Product Impurities
TLDR
This paper proposes approaches on how to establish patient centric criteria for drug substance and drug product impurity limits based on the principles outlined in ICH guideline documents and scientific literature and gives thoughts on the future perspective of this movement.
The Application of Science- and Risk-Based Concepts to Drug Substance Stability Strategies
The International Conference on Harmonization (ICH) has provided practical guidance on the amount and type of drug substance stability data needed to support marketing applications (International
The Selection and Control of Starting Materials Should be Governed by Science and Risk-Based Approaches
TLDR
A perception that a specific number of steps and/ or isolation/purification operations will always be needed to insulate API quality from unknown impurity risks remains and results in a palpable concern of inconsistent application of ICH Q11 principles.
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