Therapeutic innovation & regulatory science

Keyphrases

Publications

volume 58, number 4, 2024

Yimei Li, Robert Nelson, Rima Izem, Kristine Broglio, Rajiv Mundayat, Margaret Gamalo, Yansong Wen, Haitao Pan, Hengrui Sun, Jingjing Ye
Unlocking the Potential: A Systematic Review of Master Protocol in Pediatrics. Therapeutic innovation & regulatory science 58 (4) (2024)
Daichi Uchijima, Shingo Kano
International Comparison of Qualification Process for Medical Product Development Tools. Therapeutic innovation & regulatory science 58 (4) (2024)
Björn Koneswarakantha, Ronojit Adyanthaya, Jennifer Emerson, Frederik Collin, Annett Keller, Michaela Mattheus, Ioannis Spyroglou, Sandra Donevska, Timothé Ménard, null null
An Open-Source R Package for Detection of Adverse Events Under-Reporting in Clinical Trials: Implementation and Validation by the IMPALA (Inter coMPany quALity Analytics) Consortium. Therapeutic innovation & regulatory science 58 (4) (2024)
Shinya Watanabe, Takahiro Nonaka, Makoto Maeda, Masanobu Yamada, Narushi Sugii, Koichi Hashimoto, Shingo Takano, Tomoyoshi Koyanagi, Yoshihiro Arakawa, Eiichi Ishikawa
Recent Status of Phase I Clinical Trials for Brain Tumors: A Regulatory Science Study of Exploratory Efficacy Endpoints. Therapeutic innovation & regulatory science 58 (4) (2024)
James Signorovitch, Jialu Zhang, David Brown, Preston Dunnmon, Liang Xiu, Nicolae Done, Kristen Hsu, Yolanda Barbachano, Isabelle Lousada
Pathway for Development and Validation of Multi-domain Endpoints for Amyloid Light Chain (AL) Amyloidosis. Therapeutic innovation & regulatory science 58 (4) (2024)
Jonathan H Sussman, Ahmed Albayar, Anissa Saylany, Bhargavi R Budihal, Dominic Romeo, Jason Xu, Joshua Rosenow, Robert F Heary, William C Welch
The FDA Reclassification of Cervical Pedicle and Lateral Mass Screws: A Case Study in Regulatory History. Therapeutic innovation & regulatory science 58 (4) (2024)
Yimei Li, Robert Nelson, Rima Izem, Kristine Broglio, Rajiv Mundayat, Margaret Gamalo, Yansong Wen, Haitao Pan, Hengrui Sun, Jingjing Ye
Unlocking the Potential: A Systematic Review of Master Protocol in Pediatrics. Therapeutic innovation & regulatory science 58 (4) (2024)
Jonathan H Sussman, Ahmed Albayar, Anissa Saylany, Bhargavi R Budihal, Dominic Romeo, Jason Xu, Joshua Rosenow, Robert F Heary, William C Welch
The FDA Reclassification of Cervical Pedicle and Lateral Mass Screws: A Case Study in Regulatory History. Therapeutic innovation & regulatory science 58 (4) (2024)
Shinya Watanabe, Takahiro Nonaka, Makoto Maeda, Masanobu Yamada, Narushi Sugii, Koichi Hashimoto, Shingo Takano, Tomoyoshi Koyanagi, Yoshihiro Arakawa, Eiichi Ishikawa
Recent Status of Phase I Clinical Trials for Brain Tumors: A Regulatory Science Study of Exploratory Efficacy Endpoints. Therapeutic innovation & regulatory science 58 (4) (2024)
Daichi Uchijima, Shingo Kano
International Comparison of Qualification Process for Medical Product Development Tools. Therapeutic innovation & regulatory science 58 (4) (2024)
Zhi-Hui Song, Qiao-Ming Huang, Shan-Shan Xu, Jian-Bo Zhou, Chao Zhang
The Effect of Antihyperglycemic Medications on COVID-19: A Meta-analysis and Systematic Review from Observational Studies. Therapeutic innovation & regulatory science 58 (4) (2024)
Yimei Li, Robert Nelson, Rima Izem, Kristine Broglio, Rajiv Mundayat, Margaret Gamalo, Yansong Wen, Haitao Pan, Hengrui Sun, Jingjing Ye
Unlocking the Potential: A Systematic Review of Master Protocol in Pediatrics. Therapeutic innovation & regulatory science 58 (4) (2024)
James Signorovitch, Jialu Zhang, David Brown, Preston Dunnmon, Liang Xiu, Nicolae Done, Kristen Hsu, Yolanda Barbachano, Isabelle Lousada
Pathway for Development and Validation of Multi-domain Endpoints for Amyloid Light Chain (AL) Amyloidosis. Therapeutic innovation & regulatory science 58 (4) (2024)

volume 58, number 5, 2024

Risa Iwata, Shuichi Mochizuki, Tomoaki Hasegawa, Kensuke Ishii, Naoki Matsumaru, Katsura Tsukamoto
Preventive Effects of Bioabsorbable Anti-Adhesion Barriers on Bowel Obstruction After Colectomy in Colon Cancer Patients: A Retrospective Cohort Study Using an Insurance Claims Database. Therapeutic innovation & regulatory science 58 (5) (2024)
Sarah Condon, Thomas G Cantu, Antony Constantinou, Erin C Degnan, Monica Lungu, Marcella G Paglione, Shreya J Parikh, Joanna Szewczyk
Overdosage Section in US and EU Labeling. Therapeutic innovation & regulatory science 58 (5) (2024)
Sarah Condon, Thomas G Cantu, Antony Constantinou, Erin C Degnan, Monica Lungu, Marcella G Paglione, Shreya J Parikh, Joanna Szewczyk
Overdosage Section in US and EU Labeling. Therapeutic innovation & regulatory science 58 (5) (2024)
Alper Fatih Ardic, Nurittin Ardic
Role of Neutrophils as Therapeutic Targets in Intracerebral Hemorrhage. Therapeutic innovation & regulatory science 58 (5) (2024)
Mary E Wilhelm, Nancy Pire-Smerkanich, Frances J Richmond
Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry. Therapeutic innovation & regulatory science 58 (5) (2024)
Rominder Singh, William Wang, Aloka Chakravarty, Jun Wang, Yoshiaki Uyama
Simultaneous Global Drug Development and Multiregional Clinical Trials (MRCT): 5 Years After Implementation of ICH E17 Guidelines. Therapeutic innovation & regulatory science 58 (5) (2024)
Marijo Kambere, Hong Vu, Dana Kappel, Kukhwa Oh, Philip Budashewitz, John Concato
Qualitative Analysis of Inquiries Received by FDA Regarding Conduct of Clinical Trials during the Covid-19 Public Health Emergency. Therapeutic innovation & regulatory science 58 (5) (2024)
Colleen Watson, Frances J Richmond
EU's Medical Device Expert Panels: Analysis of Membership and Published Clinical Evaluation Consultation Procedure (CECP) Results. Therapeutic innovation & regulatory science 58 (5) (2024)
Sabah Attar, Angie Price, Collin Hovinga, Breanne Stewart, Thierry Lacaze-Masmonteil, Fedele Bonifazi, Mark A Turner, Ricardo M Fernandes
Harmonizing Quality Improvement Metrics Across Global Trial Networks to Advance Paediatric Clinical Trials Delivery. Therapeutic innovation & regulatory science 58 (5) (2024)
Sarah Condon, Thomas G Cantu, Antony Constantinou, Erin C Degnan, Monica Lungu, Marcella G Paglione, Shreya J Parikh, Joanna Szewczyk
Overdosage Section in US and EU Labeling. Therapeutic innovation & regulatory science 58 (5) (2024)
Daniel O' Mahony, Alan Lynch, Olivia McDermott
The Impact of Serialisation on Operational Efficiency and Productivity in Irish Pharmaceutical Sites. Therapeutic innovation & regulatory science 58 (5) (2024)
Marijo Kambere, Hong Vu, Dana Kappel, Kukhwa Oh, Philip Budashewitz, John Concato
Qualitative Analysis of Inquiries Received by FDA Regarding Conduct of Clinical Trials during the Covid-19 Public Health Emergency. Therapeutic innovation & regulatory science 58 (5) (2024)
Naoki Isogawa, Andy Grieve, Ryota Ishii, Kazushi Maruo
Performance Evaluation of Interim Analysis in Bioequivalence Studies. Therapeutic innovation & regulatory science 58 (5) (2024)
Joo-Hee Kim, Sera Kwon, Ju Eun Seol, Mi Hye Kim, Su Dong Kim
Regulatory Framework for Drug-Device Combination Products in the United States, Europe, and Korea. Therapeutic innovation & regulatory science 58 (5) (2024)
Mengyao Shi, Shein-Chung Chow
Statistical Analysis for Rating Scale in Clinical Trials. Therapeutic innovation & regulatory science 58 (5) (2024)
Marijo Kambere, Hong Vu, Dana Kappel, Kukhwa Oh, Philip Budashewitz, John Concato
Qualitative Analysis of Inquiries Received by FDA Regarding Conduct of Clinical Trials during the Covid-19 Public Health Emergency. Therapeutic innovation & regulatory science 58 (5) (2024)
George Wu, Spencer Childress, Zhongkai Wang, Matt Roumaya, Colleen McLaughlin Stern, Chelsea Dickens, Jeremy Wildfire
Good Statistical Monitoring: A Flexible Open-Source Tool to Detect Risks in Clinical Trials. Therapeutic innovation & regulatory science 58 (5) (2024)
Sabah Attar, Angie Price, Collin Hovinga, Breanne Stewart, Thierry Lacaze-Masmonteil, Fedele Bonifazi, Mark A Turner, Ricardo M Fernandes
Harmonizing Quality Improvement Metrics Across Global Trial Networks to Advance Paediatric Clinical Trials Delivery. Therapeutic innovation & regulatory science 58 (5) (2024)
Dawn P Richards, John Queenan, Linnea Aasen-Johnston, Heather Douglas, Terry Hawrysh, Michael Lapenna, Donna Lillie, Emily I McIntosh, Jenna Shea, Maureen Smith, Susan Marlin
Patient and Public Perceptions in Canada About Decentralized and Hybrid Clinical Trials: "It's About Time we Bring Trials to People". Therapeutic innovation & regulatory science 58 (5) (2024)
Dawn P Richards, John Queenan, Linnea Aasen-Johnston, Heather Douglas, Terry Hawrysh, Michael Lapenna, Donna Lillie, Emily I McIntosh, Jenna Shea, Maureen Smith, Susan Marlin
Patient and Public Perceptions in Canada About Decentralized and Hybrid Clinical Trials: "It's About Time we Bring Trials to People". Therapeutic innovation & regulatory science 58 (5) (2024)
Steven R Cummings, Scott Chetham, Andy Lee
A Method to Redesign and Simplify Schedules of Assessment and Quantify the Impacts. Applications to Merck Protocols. Therapeutic innovation & regulatory science 58 (5) (2024)
Colleen Watson, Frances J Richmond
EU's Medical Device Expert Panels: Analysis of Membership and Published Clinical Evaluation Consultation Procedure (CECP) Results. Therapeutic innovation & regulatory science 58 (5) (2024)
Daniel O' Mahony, Alan Lynch, Olivia McDermott
The Impact of Serialisation on Operational Efficiency and Productivity in Irish Pharmaceutical Sites. Therapeutic innovation & regulatory science 58 (5) (2024)
George Wu, Spencer Childress, Zhongkai Wang, Matt Roumaya, Colleen McLaughlin Stern, Chelsea Dickens, Jeremy Wildfire
Good Statistical Monitoring: A Flexible Open-Source Tool to Detect Risks in Clinical Trials. Therapeutic innovation & regulatory science 58 (5) (2024)
Steven R Cummings, Scott Chetham, Andy Lee
A Method to Redesign and Simplify Schedules of Assessment and Quantify the Impacts. Applications to Merck Protocols. Therapeutic innovation & regulatory science 58 (5) (2024)
Mary E Wilhelm, Nancy Pire-Smerkanich, Frances J Richmond
Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry. Therapeutic innovation & regulatory science 58 (5) (2024)
Dawn P Richards, John Queenan, Linnea Aasen-Johnston, Heather Douglas, Terry Hawrysh, Michael Lapenna, Donna Lillie, Emily I McIntosh, Jenna Shea, Maureen Smith, Susan Marlin
Patient and Public Perceptions in Canada About Decentralized and Hybrid Clinical Trials: "It's About Time we Bring Trials to People". Therapeutic innovation & regulatory science 58 (5) (2024)
Colleen Watson, Frances J Richmond
EU's Medical Device Expert Panels: Analysis of Membership and Published Clinical Evaluation Consultation Procedure (CECP) Results. Therapeutic innovation & regulatory science 58 (5) (2024)
Zachary P Smith, Joseph A DiMasi, Kenneth A Getz
New Estimates on the Cost of a Delay Day in Drug Development. Therapeutic innovation & regulatory science 58 (5) (2024)
Kristine Broglio, Freda Cooner, Yujun Wu, Mike Xiao, X Q Xue, Marina Lowen, Izuagie Ikhapoh, Philip He
A Systematic Review of Adaptive Seamless Clinical Trials for Late-Phase Oncology Development. Therapeutic innovation & regulatory science 58 (5) (2024)
George Wu, Spencer Childress, Zhongkai Wang, Matt Roumaya, Colleen McLaughlin Stern, Chelsea Dickens, Jeremy Wildfire
Good Statistical Monitoring: A Flexible Open-Source Tool to Detect Risks in Clinical Trials. Therapeutic innovation & regulatory science 58 (5) (2024)
Steven R Cummings, Scott Chetham, Andy Lee
A Method to Redesign and Simplify Schedules of Assessment and Quantify the Impacts. Applications to Merck Protocols. Therapeutic innovation & regulatory science 58 (5) (2024)
Daniel Li, Zhenzhen Xu, Shihua Wen, Revathi Ananthakrishnan, Yeonhee Kim, Khadija Rerhou Rantell, Patricia Anderson, James Whitmore, Alan Chiang
Challenges and Lessons Learned in Autologous Chimeric Antigen Receptor T-Cell Therapy Development from a Statistical Perspective. Therapeutic innovation & regulatory science 58 (5) (2024)
Mary E Wilhelm, Nancy Pire-Smerkanich, Frances J Richmond
Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry. Therapeutic innovation & regulatory science 58 (5) (2024)
Daniel O' Mahony, Alan Lynch, Olivia McDermott
The Impact of Serialisation on Operational Efficiency and Productivity in Irish Pharmaceutical Sites. Therapeutic innovation & regulatory science 58 (5) (2024)
Yingwen Dong, Gautier Paux, Kristine Broglio, Freda Cooner, Guozhi Gao, Wei He, Lei Gao, Xiaoqiang Xue, Philip He
Use of Seamless Study Designs in Oncology Clinical Development- A Survey Conducted by IDSWG Oncology Sub-team. Therapeutic innovation & regulatory science 58 (5) (2024)
Sabah Attar, Angie Price, Collin Hovinga, Breanne Stewart, Thierry Lacaze-Masmonteil, Fedele Bonifazi, Mark A Turner, Ricardo M Fernandes
Harmonizing Quality Improvement Metrics Across Global Trial Networks to Advance Paediatric Clinical Trials Delivery. Therapeutic innovation & regulatory science 58 (5) (2024)