Am J Physiol Endocrinol Metab (2013) 305(8):E94250.10.1152/ajpendo.00304.2013 259 ListEOBerrymanDEFunkKJaraAKelderBWangFet alLiver-specific GH receptor gene-disrupted (LiGHRKO) mice have decreased endocrine IGF-I, increased local IGF-I, and altered body size, body composition, and adipokine profiles
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The purpose of the NDA is to provide FDA reviewers with enough information to make the following key decisions: Comprehending whether the drug is safe and effective in its proposed use(s) Comprehending whether the benefits of the drug outweigh the risks Determining whether the drug's submitted labeling (package insert) is appropriate, and what it should include Determining whether the methods used in manufacturing the drug and the controls used to maintain its quality are sufficient to maintain the drug's identity, strength, quality, and purity
GSSG reduction occurs at the expense of NADPH, produced by the pentose phosphate pathway (PPP) from glucose oxidation
Park et al
