AIMC Topic: Quality Control

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Implementing QbD for Nano-Pharmaceuticals and Complex Formulations to Achieve Predictable and High-Quality Outcomes.

AAPS PharmSciTech
Recent advances in artificial intelligence (AI) and machine learning (ML) are revolutionizing nanopharmaceutical development by enabling data-driven formulation design, process optimization, and prediction of biological performance. AI encompasses co...

New method for online quality control of dwell position and dwell time in brachytherapy by using high-speed camera and neural networks.

Physics in medicine and biology
To develop an online quality control (QC) system for accurate assessment of dwell position and dwell time in high-dose-rate (HDR) brachytherapy, and to investigate the potential of neural networks so as to improve the robustness and stability of the ...

Mechanisms of Adeno-Associated Virus Serotype 9 Vector Characterization and Quality Control through Solid-State Nanopores.

ACS nano
Adeno-associated virus (AAV) vectors are excellent gene-delivery carriers in gene therapy; however, improperly packaged capsids produced during manufacturing can reduce potency and raise safety concerns. We introduce a machine-learning-assisted, low-...

Current state of machine learning implementation in pharmaceutical process modeling for oral solid dosage forms.

International journal of pharmaceutics
Driven by the Food and Drug Administration's Quality-by-Design initiative and the advancements of Industry 4.0, the pharmaceutical industry is transitioning from traditional batch manufacturing to advanced manufacturing. This transition requires resh...

A review of the state-of-the-art: progress in ultrasonic and acoustic techniques for quality assessment in the development and manufacturing of oral solid dosage forms - Part I: theoretical foundations and principles.

International journal of pharmaceutics
Over the past two decades, a diverse array of ultrasonic and acoustic elastic-wave techniques has been developed to non-destructively assess macro- and micro-scale properties of compressed Oral Solid Dosage (OSD) forms. These methods are increasingly...

Additive manufacturing of microneedles: a quality by design approach to clinical translation.

International journal of pharmaceutics
Transdermal drug delivery systems (TDDS) offer a painless and non-invasive route of administration but are limited by the skin barrier. Microneedles (MNs) have been shown to overcome this challenge and enable the delivery of small molecules, peptides...

Storage life prediction and quality discrimination of instant green tea: Integrating computer vision, electronic nose, and electronic tongue.

Food chemistry
Tea storage is a critical determinant in determining the quality of tea products. This study systematically investigated the quality alterations of instant green tea during storage and developed an intelligent evaluation method by integrating compute...

A comprehensive dose-volume histogram-based index for radiotherapy treatment plan quality evaluation: application to breast cancer radiotherapy.

Physics in medicine and biology
Advances in radiotherapy have increased treatment plan complexity, making manual quality evaluation more subjective and variable. While deep learning approaches offer automation in planning, evaluation remains a manual bottleneck. Existing indices ev...

Leveraging RegNet and CBAM for precise detection of honey adulteration using thermal image analysis.

Scientific reports
Honey adulteration poses a huge challenge with considerable health and economic consequences, underscoring the necessity for effective and precise quality evaluation techniques. This research introduces a novel approach for classifying levels of hone...

Artificial intelligence in the non-clinical laboratory: enhancing good laboratory and documentation practices.

International journal of pharmaceutics
Non-clinical laboratories are under increasing regulatory pressure from agencies such as the FDA, EMA, and MHRA to ensure data integrity, traceability, and compliance with Good Laboratory Practice (GLP) and Good Documentation Practice (GDP). While Ar...