المؤلفون: Rajarathnam E. Reddy (2944248), Wenbin Hu (1646995), Brian R. Lowry (11784398), Jace L. Fogle (11784401), Robert E. Malick (11784404), Greg Erexson (11784407), John M. Westerberg (11784410), Adelia L. Carragher (11784413), Emily E. Robinson (11784416), Carlos A. Orihuela (11784419), Michael C. Hillier (2526424), Steven R. Davis (1675549), Paul E. Kruk (11784422), Nathan D. Ide (2053966), Laurie Mlinar (6816839), Mathew M. Mulhern (2374549), Kenneth M. Engstrom (2311186), Elie Chaaya (11784425), Laura A. McKee (11784428), Patrick E. Manning (11784431), Pasquale Tirino (2138434), Roberta Joudioux (11784434), Lisa Cornelio (2489002)

مصطلحات موضوعية: Genetics, Pharmacology, Biotechnology, Immunology, Cancer, Mental Health, Biological Sciences not elsewhere classified, Chemical Sciences not elsewhere classified, gained considerable attention, risk mitigation studies, molecule drug substance, drug product ’, leachables ’ profile, extractables ’ studies, second step consists, release leachable impurities, leachable impurity removal, drug substance, leachable impurities, study consists, pharmaceutical product, step 3, first step, risk scoring, risk posed, risk components, via <, typically warranted, toxicity assessments, process solvent

Relation: https://figshare.com/articles/journal_contribution/Risk_Assessment_of_the_Leachables_Profile_for_Small-Molecule_Pharmaceutical_Drug_Substances/17113763

الاتاحة: https://doi.org/10.1021/acs.oprd.1c00296.s001