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WuXi General Toxicology

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Standard for Exchange of Nonclinical Data (SEND)

A Typical Timeline for Your Biologics Toxicology Program

Troubleshooting during In-House Validation of 3T3 NRU Phototoxicity Assay in WuXi AppTec

Revised CFDA Guidance on Genotoxicity Testing and Data Interpretation for Phameceuticals Intended for Human Use

Comparison Of Organ Weight In 11 to 12 Weeks Old Sprague Dawley Rats From Different Geographical Regions

A Novel and Rapid Method for Simultaneous Determination of Arginine, Ornithine, Citrulline and Urea in in vitro Human Hepatocyte

A Systematic Approach for Achieving High Extraction Recovery in LC-MS/MS Large Molecule Quantitation Assays

Comparison of Two LC-MS/MS Protein Quantitation Strategies with Trastuzumab as a Model System in Rat Pharmacokinetics Study

Liquid Chromatography and Tandem Mass Spectrometry for Quantitation of Unstable Arginine and Ornithine in the Mouse Liver, Plasma and Tumor

Development of Validated Dry Plasma Spot Assay Platform for Cassette LC-MS/MS Analysis and Comparison with Traditional Methods in Pharmacokinetics Study

Comprehensive Validation of Dried Blood Spot Methods in Therapeutic Drug Monitoring by LC-MSMS

Investigation of Pre- and Postnatal Developmental Toxicity of Caffeine in Rats

Case Study of Stability Center for Late Clinical Phase Products

Case Study of Stability Center for Commercial Products

WuXi AppTec Drug Metabolism and Pharmacokinetic Services

Large Molecule Bioanalytical Service

Spontaneous Lesions Associated with Test Article-Unrelated Deaths in Repeated Does Rat Studies

Comparison of Organ Weight (Absolute and Relative to Brain) in Wistar Rats at Different Ages

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Bill Harrison

WuXi AppTec’s Preclinical Safety Center: Suzhou, China

Hong Li

CMC Consideration for IND Application and WuXi AppTec’s Solution The WIND Program

Margaret Ma

Bioanalytical Strategies for Biologics in Preclinical Studies

Panel Discussion

Challenges and Strategies to Accelerate an IND Program

Sharon Tong

ADME and PK Attributes for Drug Discovery and Development

Yi Jin

WIND: Your Choice of Pathway to a Successful IND Program

Kay Olmstead

CMC Route to Initial IND: from Medichem to GMP Drugs

Society of Toxicology

Yi Jin

A Typical Timeline for your Biologic’s Toxicology Program

David Serota

Maximizing Your Experience and Relationship with Your CRO