000 01781 a2200493 4500
005 20250517132421.0
264 0 _c20170313
008 201703s 0 0 eng d
022 _a1096-0295
024 7 _a10.1016/j.yrtph.2016.12.011
_2doi
040 _aNLM
_beng
_cNLM
100 1 _aHarvey, James
245 0 0 _aManagement of organic impurities in small molecule medicinal products: Deriving safe limits for use in early development.
_h[electronic resource]
260 _bRegulatory toxicology and pharmacology : RTP
_cMar 2017
300 _a116-123 p.
_bdigital
500 _aPublication Type: Journal Article; Review
650 0 4 _aAnimals
650 0 4 _aClinical Trials as Topic
_xlegislation & jurisprudence
650 0 4 _aDose-Response Relationship, Drug
650 0 4 _aDrug Contamination
650 0 4 _aDrug Discovery
_xlegislation & jurisprudence
650 0 4 _aDrug and Narcotic Control
650 0 4 _aGovernment Regulation
650 0 4 _aHealth Policy
650 0 4 _aHumans
650 0 4 _aNo-Observed-Adverse-Effect Level
650 0 4 _aOrganic Chemicals
_xadverse effects
650 0 4 _aPatient Safety
_xlegislation & jurisprudence
650 0 4 _aPharmaceutical Preparations
_xanalysis
650 0 4 _aPolicy Making
650 0 4 _aQuality Control
650 0 4 _aRisk Assessment
650 0 4 _aRisk Factors
650 0 4 _aThreshold Limit Values
650 0 4 _aTime Factors
650 0 4 _aToxicity Tests
_xmethods
700 1 _aFleetwood, Andrew
700 1 _aOgilvie, Ron
700 1 _aTeasdale, Andrew
700 1 _aWilcox, Phil
700 1 _aSpanhaak, Steven
773 0 _tRegulatory toxicology and pharmacology : RTP
_gvol. 84
_gp. 116-123
856 4 0 _uhttps://doi.org/10.1016/j.yrtph.2016.12.011
_zAvailable from publisher's website
999 _c26743302
_d26743302