Therapeutic Innovation & Regulatory Science
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Publication Venue For
- Practical Issues in Clinical Inspection Process.. 53:374-380. 2019
- Defining Efficacy Estimands in Clinical Trials: Examples Illustrating ICH E9(R1) Guidelines.. 2168479019841316. 2019
- Choosing Estimands in Clinical Trials: Putting the ICH E9(R1) Into Practice.. 2168479019838827. 2019
- Effective Partnering in Conducting Benefit-Risk Patient Preference Studies: Perspectives From a Patient Advocacy Organization, a Pharmaceutical Company, and Academic Stated-Preference Researchers.. 52:507-513. 2018
- Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI's Patient Groups and Clinical Trials Project.. 52:220-229. 2018
- Patient Engagement at a Tipping Point-The Need for Cultural Change Across Patient, Sponsor, and Regulator Stakeholders: Insights From the DIA Conference, "Patient Engagement in Benefit Risk Assessment Throughout the Life Cycle of Medical Products".. 50:546-553. 2016
- Oligonucleotide-Based Drug Development: Considerations for Clinical Pharmacology and Immunogenicity.. 49:861-868. 2015
- Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28-29, 2014.. 49:623-631. 2015
- Cardiac Safety Research Consortium (CSRC): Cardiovascular Safety and Adverse Event Case Report Forms.. 49:511-513. 2015
- Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND.. 48:741-748. 2014
- Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application.. 48:200-207. 2014