Describes timing and cost for the major drug development steps by reviewing industry statistics....Less

Discusses the key data generated during pharmacology studies and how that information is used to move from animal studies to human studies. In addition, specific challenges in assessing pharmacology in biologics and small molecule drug candidates is explored....Less

Demonstrates how pharmacokinetics is used to characterize the exposure-response relationship for a drug candidate, discusses the typical endpoints calculated, and describes bioanalytical assay and validation criteria....Less

Describes the importance of toxicity studies and how the information obtained helps select compounds, establishes safety parameters of those compounds and influences animal model choice, dose selection, and routes of administration for the candidate drug. Concepts such as therapeutic margins and subjectivity in making conclusions based on sample study data are explored....Less

Explains what to include and how to complete the Common Technical Document....Less