1. Severely debilitating or life-threatening hematologic disorders: nonclinical development of pharmaceuticals Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2019 Subject(s): Drug Evaluation, Preclinical -- standardsHematologic Diseases -- drug therapyAnimalsCarcinogenicity TestsCytotoxicity Tests, ImmunologicDrug Therapy, CombinationDrug-Related Side Effects and Adverse ReactionsImmunologic TestsMutagenicity TestsPediatricsPharmacokineticsPhotochemistrySafetyToxicity TestsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. M7(R2) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk: guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2023 Subject(s): CarcinogensDrug Contamination -- prevention & controlDrug DevelopmentDrug IndustryGovernment RegulationMutagenicity TestsMutagensUnited StatesUnited States. Food and Drug Administration
