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ICH M7 Overview: Predicting, Assessing, and Controlling Mutagenic Impurities from DegradationJune 2018pdf file
Use of In Silico for Assessing DegradantsJune 2018pdf fileZeneth
Supporting Lhasa Members in a Regulatory SettingJune 2018pdf file
Mirabilis: Using Mirabilis to Support Purge Arguments Under ICH M7June 2018pdf fileMirabilis
Miniaturization of the Ames test MPAJune 2018pdf file
Mutagenicity Predictions using a Statistical SystemJune 2018pdf fileSarah Nexus
Toxicity Studies for Degradation Impurities - An Industry PerspectiveJune 2018pdf fileDerek NexusSarah Nexus
How Zeneth fits into ICH Q3DJune 2018pdf fileZeneth
Improving Toxicity Predictions through knowledge and data sharingJune 2018pdf fileDerek NexusExcipientsIntermediatesiPiEVitic Nexus
ICH M7 Use CasesJune 2018pdf fileDerek NexusSarah Nexus
iPiE 2018.1.0 Release NotesJune 2018pdf fileiPiE
Methods for Collection and Quality Assessment of Pharmacokinetic DataJune 2018pdf file
Vitic PDE 2018.2.0 Release NotesJune 2018pdf file
Intermediates Database 2018.1.0 Release NotesJune 2018pdf fileIntermediatesVitic Nexus
Excipients Database 2018.1.0 Release NotesJune 2018pdf fileVitic NexusExcipients
Supporting the Assessment of the Purging of Potential Mutagenic Impurities via Analysis of Patent LiteratureMay 2018pdf file
Flavours in AromaticityMay 2018pdf file
An Elemental Impurities Excipient Database: A Viable Tool for ICH Q3D Drug Product Risk AssessmentMay 2018
Are all Ames Strains in the OECD Mutagenicity Test Guideline 471 useful and necessary? An analysis of large mutagenicity data sets for the IWGTMay 2018pdf file
Deriving Compound Specific Exposure Limits for Chemicals Used in Pharmaceutical SynthesisMay 2018pdf file
Adjustment FactorsMay 2018pdf file
AI and PDE Data Sharing Projects for Pharmaceutical ImpuritiesMay 2018pdf file
Data Selection for Calculating the Acceptable Intake of Ethylene Oxide (CAS# 75-21-8)May 2018pdf file
Permissable Exposures Without DataMay 2018pdf file
Approaches for Establishing Limits for Different Routes of AdministrationMay 2018pdf file

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