Loading…
The Use of External Controls in FDA Regulatory Decision Making
Jahanshahi, Mahta, Gregg, Keith, Davis, Gillian, Ndu, Adora, Miller, Veronica, Vockley, Jerry, Ollivier, Cecile, Franolic, Tanja, Sakai, Sharon
Published in Therapeutic innovation & regulatory science (01.09.2021)
Published in Therapeutic innovation & regulatory science (01.09.2021)
Get full text
Journal Article
Loading…
Quality of FDM 3D Printed Medicines for Pediatrics: Considerations for Formulation Development, Filament Extrusion, Printing Process and Printer Design
Quodbach, Julian, Bogdahn, Malte, Breitkreutz, Jörg, Chamberlain, Rebecca, Eggenreich, Karin, Elia, Alessandro Giuseppe, Gottschalk, Nadine, Gunkel-Grabole, Gesine, Hoffmann, Lena, Kapote, Dnyaneshwar, Kipping, Thomas, Klinken, Stefan, Loose, Fabian, Marquetant, Tristan, Windolf, Hellen, Geißler, Simon, Spitz, Tilmann
Published in Therapeutic innovation & regulatory science (01.11.2022)
Published in Therapeutic innovation & regulatory science (01.11.2022)
Get full text
Journal Article
Loading…
Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative
Apostolaros, Maria, Babaian, David, Corneli, Amy, Forrest, Annemarie, Hamre, Gerrit, Hewett, Jan, Podolsky, Laura, Popat, Vaishali, Randall, Penny
Published in Therapeutic innovation & regulatory science (01.07.2020)
Published in Therapeutic innovation & regulatory science (01.07.2020)
Get full text
Journal Article
Loading…
Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI’s Patient Groups and Clinical Trials Project
Levitan, Bennett, Getz, Kenneth, Eisenstein, Eric L., Goldberg, Michelle, Harker, Matthew, Hesterlee, Sharon, Patrick-Lake, Bray, Roberts, Jamie N., DiMasi, Joseph
Published in Therapeutic innovation & regulatory science (01.03.2018)
Published in Therapeutic innovation & regulatory science (01.03.2018)
Get full text
Journal Article
Loading…
Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting
Strauss, David G., Gintant, Gary, Li, Zhihua, Wu, Wendy, Blinova, Ksenia, Vicente, Jose, Turner, J. Rick, Sager, Philip T.
Published in Therapeutic innovation & regulatory science (01.07.2019)
Published in Therapeutic innovation & regulatory science (01.07.2019)
Get full text
Journal Article
Loading…
Minimizing Patient Burden Through the Use of Historical Subject-Level Data in Innovative Confirmatory Clinical Trials: Review of Methods and Opportunities
Lim, Jessica, Walley, Rosalind, Yuan, Jiacheng, Liu, Jeen, Dabral, Abhishek, Best, Nicky, Grieve, Andrew, Hampson, Lisa, Wolfram, Josephine, Woodward, Phil, Yong, Florence, Zhang, Xiang, Bowen, Ed
Published in Therapeutic innovation & regulatory science (01.09.2018)
Published in Therapeutic innovation & regulatory science (01.09.2018)
Get full text
Journal Article
Loading…
Loading…
Partnering With Patients in the Development and Lifecycle of Medicines: A Call for Action
Hoos, Anton, Anderson, James, Boutin, Marc, Dewulf, Lode, Geissler, Jan, Johnston, Graeme, Joos, Angelika, Metcalf, Marilyn, Regnante, Jeanne, Sargeant, Ifeanyi, Schneider, Roslyn F., Todaro, Veronica, Tougas, Gervais
Published in Therapeutic innovation & regulatory science (01.11.2015)
Published in Therapeutic innovation & regulatory science (01.11.2015)
Get full text
Journal Article
Loading…
Factors Affecting Success of New Drug Clinical Trials
Kim, Eungdo, Yang, Jaehoon, Park, Sungjin, Shin, Kwangsoo
Published in Therapeutic innovation & regulatory science (01.07.2023)
Published in Therapeutic innovation & regulatory science (01.07.2023)
Get full text
Journal Article
Loading…
Practical Considerations and Recommendations for Master Protocol Framework: Basket, Umbrella and Platform Trials
Lu, Chengxing (Cindy), Li, Xiaoyun (Nicole), Broglio, Kristine, Bycott, Paul, Jiang, Qi, Li, Xiaoming, McGlothlin, Anna, Tian, Hong, Ye, Jingjing
Published in Therapeutic innovation & regulatory science (01.11.2021)
Published in Therapeutic innovation & regulatory science (01.11.2021)
Get full text
Journal Article
Loading…
Real World Evidence in Medical Cannabis Research
Banerjee, Rishi, Erridge, Simon, Salazar, Oliver, Mangal, Nagina, Couch, Daniel, Pacchetti, Barbara, Sodergren, Mikael Hans
Published in Therapeutic innovation & regulatory science (01.01.2022)
Published in Therapeutic innovation & regulatory science (01.01.2022)
Get full text
Journal Article
Loading…
Loading…
Considerations for Embedding Inclusive Research Principles in the Design and Execution of Clinical Trials
Peters, Ubong, Turner, Brenna, Alvarez, Daniel, Murray, Makaelah, Sharma, Aruna, Mohan, Shalini, Patel, Shilpen
Published in Therapeutic innovation & regulatory science (01.03.2023)
Published in Therapeutic innovation & regulatory science (01.03.2023)
Get full text
Journal Article
Loading…
Loading…
Loading…
Aligning Estimators With Estimands in Clinical Trials: Putting the ICH E9(R1) Guidelines Into Practice
Mallinckrodt, C. H., Bell, J., Liu, G., Ratitch, B., O’Kelly, M., Lipkovich, I., Singh, P., Xu, L., Molenberghs, G.
Published in Therapeutic innovation & regulatory science (01.03.2020)
Published in Therapeutic innovation & regulatory science (01.03.2020)
Get full text
Journal Article
Loading…
Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases
Epps, Carla, Bax, Ralph, Croker, Alysha, Green, Dionna, Gropman, Andrea, Klein, Agnes V., Landry, Hannah, Pariser, Anne, Rosenman, Marc, Sakiyama, Michiyo, Sato, Junko, Sen, Kuntal, Stone, Monique, Takeuchi, Fumi, Davis, Jonathan M.
Published in Therapeutic Innovation & Regulatory Science (01.11.2022)
Published in Therapeutic Innovation & Regulatory Science (01.11.2022)
Get full text
Journal Article
Loading…
Loading…
Analysis of FDA's Accelerated Approval Program Performance December 1992–December 2021
Beakes-Read, Ginny, Neisser, Madison, Frey, Patrick, Guarducci, Mara
Published in Therapeutic innovation & regulatory science (01.09.2022)
Published in Therapeutic innovation & regulatory science (01.09.2022)
Get full text
Journal Article