Scott W Roberts

4PUBLICATIONS
0CO-AUTHORS
Medical molecular engineering of nucleic acids and proteinsPharmacology and pharmaceutical sciences not elsewhere classified
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Publications (4)

|Oct 03, 2025
Ensuring Medical Product Patient Access Through Application of Recently Improved Global Chemistry, Manufacturing and Control Regulatory Frameworks: A Case Study Utilizing a Multi-Product PACMP.

Sunny Kamlesh Dave, Christine Ørting, Scott W Roberts

|Sep 04, 2024
A Risk-Based Assessment for Determining the Pharmacokinetic Comparability Requirements of Biologic-Device Combination Products Administered by Subcutaneous Injection.

Mark Klitgaard Nøhr, Shaik Rizwan Waheed, Rasmus Juul Kildemoes

|Nov 18, 2022
Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefit, and Case Studies.

Scott W Roberts, Tara Laura Brandt Elvang, Laila Syed

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