Extractables and Leachables: Characterization of Drug Products, Packaging, Manufacturing and Delivery Systems, and Medical Devices

Name: Extractables and Leachables: Characterization of Drug Products, Packaging, Manufacturing and Delivery Systems, and Medical Devices
Brand: WILEY US
SKU: 875907
Price: 187.85 EUR
Availability: InStock

DENNIS JENKE

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187,85 €

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Status dobavljivosti: 3-5 delovnih dni

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ISBN

9781119605072

Mladinska knjiga ID

875907

Leto izida

2022

Datum izida

05.10.2022

Velikost (šxdxv)

150 × 250 × 25

Status dobavljivosti

3-5 delovnih dni

Jezik

ANG

Založnik

WILEY US

Avtor

DENNIS JENKE

Opis

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.