Cette étude propose une analyse technique complète des demandes d'informations réglementaires et des rappels de produits nutraceutiques dans dix pays, soulignant les différences de définitions, de cadres réglementaires et de procédures de rappel. Les nutraceutiques, notamment les compléments alimentaires, les aliments fonctionnels et les produits à base de plantes, ont acquis une importance mondiale en raison de leur rôle dans la promotion de la santé et la prévention des maladies. Cependant, l'absence de réglementation harmonisée entraîne des problèmes de sécurité, de...

Diese Studie bietet einen umfassenden technischen Überblick über regulatorische Anfragen und Produktrückrufe von Nutrazeutika in zehn Ländern und hebt Unterschiede bei Definitionen, regulatorischen Rahmenbedingungen und Rückrufverfahren hervor. Nutrazeutika, darunter Nahrungsergänzungsmittel, funktionelle Lebensmittel und pflanzliche Produkte, haben aufgrund ihrer Rolle bei der Gesundheitsförderung und Krankheitsprävention weltweit an Bedeutung gewonnen. Das Fehlen harmonisierter Vorschriften führt jedoch zu Herausforderungen hinsichtlich Sicherheit, Qualität und Compliance. Die...

This study provides a comprehensive technical review of regulatory queries and product recalls of nutraceuticals across ten countries, highlighting differences in definitions, regulatory frameworks, and recall procedures. Nutraceuticals, including dietary supplements, functional foods, and herbal products, have gained global importance due to their role in health promotion and disease prevention. However, lack of harmonized regulations leads to safety, quality, and compliance challenges. The research analyzes recall data from 2019 to 2021 in regions such as America, Australia, Canada,...

This book presents a comprehensive study on the stability of rifampicin, a first-line anti-tuberculosis drug, through method development, validation, and characterization of its degradation products. It begins with an overview of tuberculosis, rifampicin's pharmacological profile, and the importance of stability-indicating methods in pharmaceutical quality control. Using HPLC and LC-MS techniques, the study optimizes chromatographic conditions and develops a validated stability-indicating method as per ICH guidelines. Forced degradation experiments under acidic, alkaline, oxidative,...

The book "Studies on Pharmacognostic,Pharmacological and Antimicrobial Aspects of Solanum sisymbriifolium" presents a systematic investigation into the medicinal potential of this plant. It begins with the significance of herbal medicines and their role in primary healthcare, emphasizing the need for scientific validation. The study focuses on pharmacognostic evaluation, including macroscopic, microscopic, and physicochemical parameters to authenticate and standardize the plant material. Successive solvent extractions were performed, followed by phytochemical screening, TLC, and HPTLC...

Brexit has significantly reshaped pharmaceutical product submissions by separating the UK from the EU's centralized regulatory framework. Before Brexit, the European Medicines Agency (EMA) oversaw marketing authorizations, ensuring harmonized access across member states. Now, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) independently regulates medicines, requiring separate applications for UK and EU markets. This has led to duplication of dossiers, increased costs, and potential delays in patient access to innovative medicines. The loss of EU funding, research...

A simple, sensitive, and selective HPLC method was developed and validated for the simultaneous estimation of Amlodipine besylate (AML) and Indapamide (IND) in human plasma for application in pharmacokinetic, bioequivalence, and bioavailability studies. AML, a calcium channel blocker, and IND, a thiazide-like diuretic, are widely prescribed in combination for hypertension management. The method employed liquid-liquid extraction using diethyl ether and dichloromethane, followed by chromatographic separation on a C18 column with a methanol-octane sulfonic acid mobile phase (79:21 v/v) at a flow...