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doi: 10.1016/j.molmet.2022.101550, PMID: [DOI] [PMC free article] [PubMed] [Google Scholar] 34.Marinho TS, Martins FF, Cardoso LEM, Aguila MB, Mandarim-de-Lacerda CA

For most patients, reaching goal weight does not signal the end of treatment but rather a transition from the weight loss phase to the weight maintenance phase, which typically requires continued pharmacological support for optimal outcomes as long as benefits outweigh risks

doi: 10.1515/jpem-2019-0389 35 KimYMLeeYJKimSYCheonCKLimHH

9 Pharmacologic Approaches to Glycemic Treatment. Standards of Care in Diabetes2024

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Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b))." 7 Detailed Analysis of the Violation The "Administrator Rights" Epidemic: Laboratory staff were granted "administrator rights," which allowed them "uncontrolled access to delete or modify files" on HPLC, GC, and FTIR systems.7 The FDA explicitly noted the lack of "segregation of firm personnel involved with laboratory testing from those with administrator rights".7 This violation mirrors those seen in the US and China, indicating a global challenge in managing legacy instrument software where "Admin" access is often the default setting required to run the instrument