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BioEntrepreneurship: Navigating the Global Regulatory Pathway
The document outlines key aspects of drug development and regulatory pathways, emphasizing the importance of following guidelines for both nonclinical and clinical trials. It details stages from exploratory research to phase I-III clinical studies, highlighting regulatory requirements, including Good Laboratory Practices (GLP) and Investigational New Drug (IND) regulations. It also discusses the differences in clinical trial applications (CTAs) between the U.S. and Canada, as well as the dynamics of IND submissions and amendments.
![Abbreviated New Drug Application [ANDA]](https://cdn.slidesharecdn.com/ss_thumbnails/abbreviatednewdrugapplicationanda-160619062810-thumbnail.jpg?width=640&height=640&fit=bounds)
