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Scott W Roberts

Showing results (41-50 of 47) with videos related to

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The AAPS Journal|July 14, 2021
Meeting Report: N-Nitrosamine Impurity Control Strategies in the Pharmaceutical and Biotechnology IndustriesScott W Roberts, Andrew Lennard, Ganapathy Mohan, et al.
The AAPS Journal|September 4, 2024
A Risk-Based Assessment for Determining the Pharmacokinetic Comparability Requirements of Biologic-Device Combination Products Administered by Subcutaneous InjectionMark Klitgaard Nøhr, Shaik Rizwan Waheed, Rasmus Juul Kildemoes, et al.
Therapeutic Innovation & Regulatory Science|November 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 StudiesScott W Roberts, Tara Laura Brandt Elvang, Laila Syed, et al.
Therapeutic Innovation & Regulatory Science|December 6, 2022
Correction: 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 StudiesScott W Roberts, Tara Laura Brandt Elvang, Laila Syed, et al.
AAPS Open|December 19, 2022
Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment AidMarquerita Algorri, Ajay Acharya, James Bernstein, et al.
The Journal of Organic Chemistry|May 7, 2016
Telescoped Process to Manufacture 6,6,6-Trifluorofucose via Diastereoselective Transfer Hydrogenation: Scalable Access to an Inhibitor of Fucosylation Utilized in Monoclonal Antibody ProductionMichal M Achmatowicz, John G Allen, Matthew M Bio, et al.
Journal of Pharmaceutical Sciences|June 14, 2025
Predictive Stability in Biopharmaceuticals and Vaccines: Perspectives and Recommendations Towards Accelerating Patient AccessDaniel Skomski, Andrea Ji, Drago Kuzman, et al.
Pageof 5

Showing results (41-50 of 47) with videos related to

Sort By:
Pageof 5
You have reached the last page of results.This site can display upto 47 results.
The AAPS Journal|July 14, 2021
Meeting Report: N-Nitrosamine Impurity Control Strategies in the Pharmaceutical and Biotechnology IndustriesScott W Roberts, Andrew Lennard, Ganapathy Mohan, et al.
The AAPS Journal|September 4, 2024
A Risk-Based Assessment for Determining the Pharmacokinetic Comparability Requirements of Biologic-Device Combination Products Administered by Subcutaneous InjectionMark Klitgaard Nøhr, Shaik Rizwan Waheed, Rasmus Juul Kildemoes, et al.
Therapeutic Innovation & Regulatory Science|November 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 StudiesScott W Roberts, Tara Laura Brandt Elvang, Laila Syed, et al.
Therapeutic Innovation & Regulatory Science|December 6, 2022
Correction: 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 StudiesScott W Roberts, Tara Laura Brandt Elvang, Laila Syed, et al.
AAPS Open|December 19, 2022
Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment AidMarquerita Algorri, Ajay Acharya, James Bernstein, et al.
The Journal of Organic Chemistry|May 7, 2016
Telescoped Process to Manufacture 6,6,6-Trifluorofucose via Diastereoselective Transfer Hydrogenation: Scalable Access to an Inhibitor of Fucosylation Utilized in Monoclonal Antibody ProductionMichal M Achmatowicz, John G Allen, Matthew M Bio, et al.
Journal of Pharmaceutical Sciences|June 14, 2025
Predictive Stability in Biopharmaceuticals and Vaccines: Perspectives and Recommendations Towards Accelerating Patient AccessDaniel Skomski, Andrea Ji, Drago Kuzman, et al.
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