Ennen Memmoa muistiinpanoni olivat hajallaan PDF-tiedostoissa. Nyt työtila kokoaa kaiken yhteen – näen tarkalleen, mitä on vielä opiskeltavana.
Learn to address the safety aspects of packaged drug products and medical devices
Pharmaceutical drug products and medical devices are expected to be effective and safe to use. This includes minimizing patient, user or product exposure to impurities leached from these items when the drug product is administered or when the medical device is used. Clearly, patient or user exposure to leachables must not adversely impact their health and safety. Furthermore, these impurities must not adversely affect key quality attributes of the drug product or medical device, including its manufacturability, stability, efficacy, appearance, shelf-life and conformance to standards.
Extractables and leachables are derived from the drug product’s packaging, manufacturing systems and/or delivery systems or from the medical device’s materials of construction. It is imperative to understand and quantify the release of extractables from these items, the accumulation of leachables in drug products and the release of leachables from medical devices. Once extractables and leachables have been discovered, identified and quantified, their effect on the key product or device quality attributes, including safety, must be systematically and scientifically established according to recognized, rigorous and relevant regulatory and compendial standards and industry-driven best practices.
In Extractables and Leachables, the chemical compatibility (including safe use) of drugs (and their containers, delivery devices and manufacturing systems) and medical devices is examined at length, focusing particularly on how trace-level extractables and leachables affect the quality and safety of a medical product and how to assess the magnitude of the effect. This is accomplished by addressing the two critical activities required to develop, register and commercialize safe, effective and affordable clinical therapies; measuring extractables and leachables (chemical characterization) and assessing their impact (for example, toxicological safety risk assessment). Each of these activities is addressed in-depth, based on the existing and developing international regulations and guidelines, current published literature and the author’s extensive personal experience. Written by a key contributor to standards, guidelines, recommended practices and the scientific literature, the book provides “insider” insights beyond those gained by merely reading the relevant texts. Given that the rapidly evolving extractables and leachables landscape, this book provides the most current and crucial information on new and forthcoming regulations and best practices.
Extractables and Leachables readers will also find:
Extractables and Leachables is the essential reference for pharmaceutical scientists, analytical chemists, regulatory affairs professionals, engineers, and toxicologists in areas such as product research and development, product registration and approval, regulatory affairs, analytical science, quality control, and manufacturing.
Ennen Memmoa muistiinpanoni olivat hajallaan PDF-tiedostoissa. Nyt työtila kokoaa kaiken yhteen – näen tarkalleen, mitä on vielä opiskeltavana.
Memmon yhteenvedot ovat kultaa ennen kokeita. Minun ei tarvitse lukea 800 sivua uudelleen kaksi viikkoa ennen – vain tärkeimmät osat.
AI-chat on pelastanut minut useammin kuin kerran tenttiä edeltävänä iltana. Kysyn vain, kunnes ymmärrän – ilman, että tarvitsee odottaa opiskeluryhmän vastausta.
Visat osuvat juuri siihen, mitä minun tarvitsee tietää. Memmo seuraa, mihin jään jumiin – joten harjoittelen vain sitä, mikä on sen arvoista.
Muistikortit toistuvalla harjoittelulla ovat taikaa. Memmo tietää, milloin olen unohtamassa jotain, ja tuo sen takaisin.
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