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false falseIn the development of drugs for human use, FDA requires that absorption, distribution, metabolism, and excretion (ADME) studies be conducted as Phase 1 investigations prior to more extensive clinical trials. These ADME materials must be manufactured in compliance with escalating Good Manufacturing Practice requirements including well defined documented procedures, adequately controlled equipment, and accurate and consistently recorded data from production and testing. Consistent with the stage of clinical development, the intent of these requirements also applies to the synthesis of radioactive drug substances. This has compelled the creative integration of escalating GMP with the many challenges already inherent in radiosynthesis and analysis. Also, because of the time sensitive nature of these expensive human studies, a further demand facing organizations conducting in Phase 1 is the adherence to strict and absolute deadlines. To assure compliance and to help meet aggressive deadlines, our laboratories have performed GMP* synthesis and analysis appropriate for Phase 1 studies for decades and have participated in the evolution of this important service for the pharmaceutical industry.
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*Consistent ICH Q7A, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, September, 2016, Section 19, API's for Use in Clinical Trials. 爱游戏平台注册登录 Life and Analytical Sciences has established a custom radiosynthesis process which provides acceptable GMP compliance and the assurance of quality for early drug studies.
**The purpose of radiochemical stability testing is to provide an indication of how the purity of the radiochemical varies with time under the influence of various temperatures during the short period from time of synthesis to investigational use. The study is not intended to establish an expiration date nor does it replace a formal stability study for the drug product.
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