Written for practitioners in both the drug and biotechnology
industries, this handbook carefully compiles current regulatory
requirements on the validation of new or modified analytical
methods. Shedding light on method validation from a practical
standpoint, it contains practical, up-to-date guidelines for
analytical method validation. It also covers development,
optimization, validation, and transfer of many different types of
methods used in the regulatory environment. Simplifying the overall
process of method development, optimization and validation, the
guidelines in the Handbook apply to both small molecules in the
conventional pharmaceutical industry, as well as the biotech
industry.
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