GerriBaerMDFAAP

PubMed

• Measuring Clinical Benefit in Neonatal Randomized Clinical Trials: Challenges and Opportunities.
  An N Massaro, Beth Boyer, Mira Gill, Dure Kim, Matthew Laughon, Michele Walsh, Monica E Lemmon, Betsy Pilon, Gerri Baer> ;The Journal of Pediatrics. 2024 Feb 22
• 3 citations
  Scientific, ethical, and legal considerations for the inclusion of pregnant people in clinical trials.
  Catherine A Sewell, Sarah M Sheehan, Mira S Gill, Leslie Meltzer Henry, Christina Bucci-Rechtweg, Anne D Lyerly, Leslie C McKinney, Kimberly P Hatfield, Gerri R Baer, ...> ;American Journal of Obstetrics and Gynecology. 2022 Dec 1
• 11 citations
  Prospect of Direct Benefit in Pediatric Trials: Practical Challenges and Potential Solutions.
  Melanie Bhatnagar, Sarah Sheehan, Isha Sharma, Gerri Baer, Dionna J Green, Susan McCune, Steven Joffe, Donna L. Snyder> ;Pediatrics. 2021 May 1
• 76 citations
  Approaches to dose finding in neonates, illustrating the variability between neonatal drug development programs
  John N. van den Anker, Susan McCune, Pieter Annaert, Gerri Baer, Yeruk Mulugeta, Ramy Abdelrahman, Kunyi Wu, Kevin Krudys, Jeffrey W. Fisher, William Slikker, Connie L...> ;Pharmaceutics. 2020 Jul 20
• 2 citations
  Advancing Therapeutic Development for Pulmonary Morbidities Associated with Preterm Birth
  Sarah Sheehan, Gerri Baer, Morgan H. Romine, Lynn D. Hudson, Robert Lim, Elektra J. Papadopoulos, Michelle Campbell, Gregory W. Daniel, Susan McCune> ;Therapeutic Innovation & Regulatory Science. 2020 Apr 27
• 14 citations
  Standardizing Safety Assessment and Reporting for Neonatal Clinical Trials
  Jonathan M. Davis, Gerri Baer, Susan McCune, Agnes Klein, Junko Sato, Laura Fabbri, Alexandra Mangili, Mary A Short, Susan Tansey, Barry Mangum, Isamu Hokuto, Hidefumi...> ;The Journal of Pediatrics. 2020 Apr 1
• 37 citations
  Development of a neonatal adverse event severity scale through a Delphi consensus approach
  Thomas Salaets, Mark A. Turner, Mary A Short, Robert M. Ward, Isamu Hokuto, Ronald L. Ariagno, Agnes Klein, Sandra Sundquist Beauman, Kelly C. Wade, Merran Thomson, Ev...> ;Archives of Disease in Childhood. 2019 Dec 1
• 29 citations
  Necrotizing Enterocolitis: Using Regulatory Science and Drug Development to Improve Outcomes
  , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , > ;The Journal of Pediatrics. 2019 Sep 1
• 27 citations
  Renal Clearance in Newborns and Infants: Predictive Performance of Population-Based Modeling for Drug Development.
  Jian Wang, Shaun S. Kumar, Catherine M.T. Sherwin, Robert M. Ward, Gerri Baer, Gilbert J. Burckart, Yaning Wang, Lynne Yao> ;Clinical Pharmacology and Therapeutics. 2019 Jun 1
• 5 citations
  Neonatal Safety Information Reported to the FDA During Drug Development Studies.
  Debbie Avant, Gerri Baer, Jason N. Moore, Panli Zheng, Alfred Sorbello, Ronald L. Ariagno, Lynne Yao, Gilbert J. Burckart, Jian Wang> ;Therapeutic Innovation & Regulatory Science. 2018 Jan 1
• 12 citations
  Enrollment of Neonates in More Than One Clinical Trial
  Jonathan M. Davis, Gerri Baer, Ronald J. Portman, Robert M. Nelson, Linda Storari, Jacob V Aranda, Ralph Bax, Anne Zajicek, Agnes Klein, Mark A. Turner, Simin K. Bayga...> ;Clinical Therapeutics. 2017 Oct 1
• 20 citations
  Challenges and strategies to facilitate formulation development of pediatric drug products: Safety qualification of excipients.
  Lorrene A. Buckley, Smita Salunke, Karen C Thompson, Gerri Baer, Darren Fegley, Mark A. Turner> ;International Journal of Pharmaceutics. 2017 Jul 17
• 1 citations
  Collaboration in Regulatory Science to Facilitate Therapeutic Development for Neonates.
  Susan McCune, Yeruk Mulugeta, Gerri Baer> ;Current Pharmaceutical Design. 2017 Jan 1
• 16 citations
  Ethical challenges in neonatal research: Summary report of the ethics group of the newborn drug development initiative.
  Gerri R. Baer, Robert M. Nelson> ;Clinical Therapeutics. 2006 Sep 1
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