Verification and Validation of Computational Models Used in Biopharmaceutical Manufacturing: Potential Application of the ASME Verification and Validation 40 Standard and FDA Proposed AI/ML Model Life Cycle Management Framework.

A wide variety of computational models covering statistical, mechanistic, and machine learning (locked and adaptive) methods are explored for use in biopharmaceutical manufacturing. Limited discussion exists on how to establish the credibility of a computational model for application in biopharmaceutical manufacturing. In this work, we tried to use the American Society of Mechanical Engineers (ASME) Verification and Validation 40 (V&V 40) standard and FDA proposed AI/ML model life cycle management framework for Software as a Medical Device (SaMD) in biopharmaceutical manufacturing use cases, by applying to a set of curated hypothetical examples.

Relationships between coordination, active drag and propelling efficiency in crawl.

This study examines the relationships between the index of coordination (IdC) and active drag (D) assuming that at constant average speed, average drag equals average propulsion. The relationship between IdC and propulsive efficiency (ep) was also investigated at maximal speed. Twenty national swimmers completed two incremental speed tests swimming front crawl with arms only in free condition and using a measurement of active drag system.

Data modelling reveals inter-individual variability of front crawl swimming.

Objectives: In accordance with dynamical systems theory, which assumes that motor behaviour emerges from interacting constraints (task, organismic, environmental), this study explored the functional role of inter-individual variability in inter-limb coordination.

Design: 63 front crawl swimmers with a range of characteristics (gender, performance level, specialty) performed seven intermittent graded speed bouts of 25m in front crawl.

Methods: Each bout was video-taped with a side-view camera from which speed, stroke rate, stroke length and index of arm coordination (IdC) were analysed for three cycles.