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FDA Orphan Drug Designation for Rare Diseases

An estimated 30 million people in the United States are afflicted with rare (orphan) diseases or conditions; however, the availability of novel treatments for these diseases and conditions has been historically low compared to conditions…

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Common Misconceptions About PBPK Modeling

As Physiologically Based Pharmacokinetic (PBPK) modeling becomes more widely used in regulatory submissions, there are some common misconceptions that have been brought to our attention. We would like to dispel or…

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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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