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What is a 505(b)(2)?

The 505(b)(2) New Drug Application (NDA) is a streamlined NDA process in which the applicant relies upon one or more investigations conducted by someone other than the applicant and for…

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Common Misconceptions About QSP Modeling

As Quantitative Systems Pharmacology (QSP) modeling is a relatively new field, there are some common misconceptions that have been brought to our attention. We would like to dispel or provide…

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