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Therapeutic Protein

Dual Filing your IND Package: Planning Pays Off

Dual Filing your IND Package: Planning Pays Off

Navigating the Investigational New Drug (IND) submission process for your drug development program can be a complex process, especially when filing with various regulatory agencies and pursuing multiple markets. However, dual, or globally filing an IND package can...

New U.S. FDA DDI Draft Guidance for Therapeutic Proteins

New U.S. FDA DDI Draft Guidance for Therapeutic Proteins

Preclinical drug-drug interactions (DDI) studies provide preliminary analysis and predict risk potentials for the investigated compounds when co-administrated with other drugs during future in-human trials. Knowledge pertaining to DDI studies is still rapidly...