کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
5856291 1131973 2015 12 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Preclinical assessment of abuse liability of biologics: In defense of current regulatory control policies
ترجمه فارسی عنوان
ارزیابی پیشآزمون از سوء استفاده از مسئولیت زیست شناسی: در دفاع از سیاست های کنترل فعلی کنترل
کلمات کلیدی
ایمنی مواد مخدر، کنترل مواد مخدر، مسئولیت سوء استفاده، بیولوژیک، مولکول کوچک، مولکول بزرگ،
موضوعات مرتبط
علوم زیستی و بیوفناوری علوم محیط زیست بهداشت، سم شناسی و جهش زایی
چکیده انگلیسی
Current regulatory policies of both the US Food and Drug Administration and Drug Enforcement Administration do not delineate automatic exceptions for biologics with respect to preclinical assessments for abuse liability of all new entities. As defined in current guidance documents and drug control policies, an exception may be given upon thorough review of available data, therapeutic target and in consultation with the Controlled Substances Staff within the Center for Drug Evaluation and Research of the FDA, but a blanket exception for all biological entities is not currently available. We review the abuse liability testing of four known biologics with definitive positive abuse liability signals in the three core abuse liability assays, self-administration, drug discrimination, and dependence potential described in the FDA draft guidance document. Interestingly, while all four examplars have positive abuse liability signals in all three assays, two of these biologics are controlled under the Comprehensive Drug Abuse and Control Act (CSA, 1970) and the other two are not currently controlled. Admittedly, these four biologics are small molecule entities. However, there is no reference to “molecular size” in the legally-binding statutory definition of biologics under the FD&C act or in the Controlled Substances Act. Neither of these drug control policy mandates have a bifurcated control status in which to make exceptions based solely on molecular size. With the current pharmaceutical focus on new technologies, such as “Trojan Horses”, targeting the active transport of large molecule entities directly into the CNS, an argument to automatically exempt new molecular entities solely on molecular size is untenable. We argue that for the safety and health of general public the current regulatory control status be maintained until definitive criteria for exceptions can be identified and amended to both the FD&CA and CSA, if warranted.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Regulatory Toxicology and Pharmacology - Volume 73, Issue 1, October 2015, Pages 43-54
نویسندگان
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