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Regenerative medicine
Published in Yann Joly, Bartha Maria Knoppers, Routledge Handbook of Medical Law and Ethics, 2014
While product classification is important for the regulatory path, the technical standards used to evaluate RM products will dictate the difficulty in navigating this path. If clear standards (addressing specifications, methods, practices and/or definitions) are in place, a product’s variability will be minimized and its safety will improve. Standard setting regulations and guidelines require that scientifically established norms and requirements (i.e. standards) be followed. Examples include Current Good Manufacturing Practice (CGMP) and Current Good Tissue Practice (CGTP). An Ernst & Young review concluded there was a significant, yet often unrecognized, role for standards in creating and developing emerging technologies (BIS 2011: 35).
19th Annual Meeting of the Safety Pharmacology Society: regulatory and safety perspectives for advanced therapy medicinal products (cellular and gene therapy products)
Published in Expert Opinion on Drug Safety, 2020
Icilio Cavero, Diane Seimetz, David Koziel, Wolfram-Hubertus Zimmermann, Henry H Holzgrefe
Mitigation strategies concerning potential adverse effects of ATMPs are generally product-specific. However, standard Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) should be applied for the manufacture and development of any ATMP or CGTP. Additional product-specific considerations may include highly variable starting materials, lack of reference standards, and/or the presence of multiple active agents in the final product, which may interact in an unanticipated manner. The early selection of the most suitable starting materials and lead candidates for the envisaged purpose can contribute to the effective mitigation of potential safety and efficacy risks and uncertainties that could appear later in the development process [2].
Genotoxic, biochemical and histopathological studies to assessment the topiramate hepatorenal toxicity in mice
Published in Drug and Chemical Toxicology, 2022
Aida I. El Makawy, Dalia M. Mabrouk, Faten M. Ibrahim, Kawkab A. Ahmed
Topiramate is a sulphamate-substituted monosaccharide has wide mode of action and confirmation of usefulness in episodic or chronic migraine patients (Spritzer et al. 2016). Topiramate is effective popular migraine prophylaxis that is accepted for utilize in adults and teenagers (Marmura 2014). It is hypothesized to thwart migraine by inhibiting sodium channels, increasing γ-aminobutyric acid–induced chloride flux, and prevent glutamate and carbonic anhydrase enzymes, which interact with diverse ion channels by either enhancing ion channel activity as in GABAA receptors, or reducing ion channel activity, as in voltage-activated Na + channels, Ca2+ channels and AMPA/kainate receptors (Alexander, CGTP Collaborators et al. 2013).