Planning 

• Drug substance requirements

• Study requirements
• Timelines
• Cost analyses 
• Safety Assessment Studies
• Protocol development
• Selection of species for studies
• Competitive bids
• Evaluation and qualification of toxicology laboratories
• Study conduct and monitoring
• Reporting
• Filing with regulatory agencies
  

Study Types (GLP)

    General Toxicology 

• Acute toxicology studies
• IND-enabling studies 
• Subchronic and chronic toxicology studies
• 2-year rat and mouse carcinogenicity studies

    Reproductive Toxicology

• Fertility (Segment I)
  
• DRFs for Developmental Studies
• Developmental (Segment II)
• Pre-/Postnatal (Segment III)
  

    Genetic Toxicology

• In vitro assays: Bacterial reverse mutation (Ames), Chromosomal Aberration assay, Mouse Lymphoma Assay
• In vivo assays: Mouse or rat micronucleus assay
• Additional assays
  

    Safety Pharmacology

• Central nervous system studies (modified Irwin)
• Cardiovascular system studies
• Respiratory system studies
• hERG, Purkinje and myocyte assays

PK/ADME Studies

• GLP pharmacokinetics in rodent and non-rodent 
• In vivo ADME studies
• In vitro ADME studies
  

PK/TK Analysis and Reporting

• Selection of dose levels and time points for blood collection
• Manage outsourced GLP plasma analysis validation and sample analysis
• PK/TK analysis of plasma concentration data using WinNonlin (nonclinical and clinical)
  
• Professional PK/TK report writing
  

Regulatory Document Preparation

TSI can assist with regulatory document preparation by writing the toxicology, ADME/PK portions of the following documents:

• Pre-IND meeting
• IND (Item 8)
• Investigator’s Brochure
• Annual updates to IND
• ICH Common Technical Document
• NDA (Item 5)
• Regulatory Meetings

TSI can assist with preparations, and be present at meetings with regulators to present toxicology data. 

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Contact: TGrizzle@toxicologyservices.net