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Pharmacovigilance is the science of monitoring the effects of medicinal products to identify and evaluate potential adverse reactions and provide necessary and timely risk mitigation measures. Intelligent automation technologies have a strong potential to automate routine work and to balance resource use across safety risk management and other pharmacovigilance activities. While emerging technologies such as artificial intelligence (AI) show great promise for improving pharmacovigilance with their capability to learn based on data inputs, existing validation guidelines should be augmented to verify intelligent automation systems. While the underlying validation requirements largely remain the same, additional activities tailored to intelligent automation are needed to document evidence that the system is fit for purpose. We propose three categories of intelligent automation systems, ranging from rule-based systems to dynamic AI-based systems, and each category needs a unique validation approach. We expand on the existing good automated manufacturing practices, which outline a risk-based approach to artificially intelligent static systems. Our framework provides pharmacovigilance professionals with the knowledge to lead technology implementations within their organizations with considerations given to the building, implementation, validation, and maintenance of assistive technology systems. Successful pharmacovigilance professionals will play an increasingly active role in bridging the gap between business operations and technical advancements to ensure inspection readiness and compliance with global regulatory authorities.

Odor poses a growing concern in clothing and apparel applications due to laundering limitations at managing odor-causing microorganisms. Herein, a novel silver-polymer complex was applied to textile materials and studied using quantitative antimicrobial assays, gas chromatography techniques, and odor panel sensory tests to ascertain odor control function and e ectiveness. A known chemical odor pathway involving leucine conversion to isovaleric acid was studied and found to be disrupted in silver-treated fabrics. Furthermore, its odor absorption function was con rmed with up to 90% retention of select thiol and fatty acid odors at body temperature in a model odor bouquet. Lastly, human sensory studies were used to support laboratory odor measurements using seven-day wear trials and milk odor generation techniques a er 50 launderings.

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Upper respiratory tract infections (URTIs) are illnesses caused by an acute infection which involves the upper respiratory tract: nose, sinuses, pharynx or larynx. Roxithromycin (macrolide antibiotic) and ambroxol HCl (mucolytic) are used for this treatment. The dual release system of roxythromycin and ambroxol HCl was successfully prepared by bi-layer tablet approach for management of URTI. Quick release of roxithromycin was achieved by using disintegrants and slow release of ambroxol HCl was achieved by using matrix formulation of drug with HPMC K4M and ethyl cellulose. The 32 full factorial design was adopted for optimization of polymer concentration to achieve identical drug release with theoretical dissolution profile. The amount of HPMC K4M and ethyl cellulose were selected as independent variable and the similarity factor with theoretical dissolution profile and percentage drug release at 10th hr was selected as dependent variables. The prepared dual release tablets were evaluated for physical parameters, drug content, in vitro drug release study, etc. All the parameters were found to be acceptable in range. As the concentration of HPMC K4M is increased, the drug release decreases and the effect of ethyl cellulose was found to be less compared to HPMC K4M.