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In autoimmune diseases such as lupus, rheumatoid arthritis, and multiple sclerosis, chronic inflammation and oxidative stress can damage tissues and interfere with immune tolerance

Maksimovich., I.K

[697] Section 1860D-14B(b)(5)(B)(ii) of the Act further states that for a Part D rebatable drug, the term line extension means, a new formulation of the drug, such as extended release formulation, but does not include an abuse-deterrent formulation of the drug (as determined by the Secretary), regardless of whether such abuse-deterrent formulation is an extended release formulation. This language is identical to the definition of line extension in section 1927(c)(2)(C) of the Act

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37,545 For example, in some initial studies, reaction volumes of 2 mL, 50 mL, and 1 L all produced human insulin-like growth factor-1 (IGF-1) at the same rate in stirred tank reactors