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  1. Article

    Open Access

    Improving Development of Drug Treatments for Pregnant Women and the Fetus

    The exclusion of pregnant populations, women of reproductive age, and the fetus from clinical trials of therapeutics is a major global public health issue. It is also a problem of inequity in medicines develop...

    Anna L. David, Homa Ahmadzia in Therapeutic Innovation & Regulatory Science (2022)

  2. Article

    Open Access

    The culture of research communication in neonatal intensive care units: key stakeholder perspectives

    To assess the perspectives of neonatologists, neonatal nurses, and parents on research-related education and communication practices in the neonatal intensive care unit (NICU).

    Jennifer Degl, Ronald Ariagno, Judy Aschner, Sandra Beauman in Journal of Perinatology (2021)

  3. Article

    Correction to: How is the Pharmaceutical Industry Structured to Optimize Pediatric Drug Development? Existing Pediatric Structure Models and Proposed Recommendations for Structural Enhancement

    The article How is the Pharmaceutical Industry Structured to Optimize Pediatric Drug Development? Existing Pediatric Structure Models and Proposed Recommendations for Structural Enhancement, written by Thomas ...

    Thomas Severin, Solange Corriol-Rohou in Therapeutic Innovation & Regulatory Science (2020)

  4. Article

    Open Access

    How is the Pharmaceutical Industry Structured to Optimize Pediatric Drug Development? Existing Pediatric Structure Models and Proposed Recommendations for Structural Enhancement

    Pediatric regulations enacted in both Europe and the USA have disrupted the pharmaceutical industry, challenging business and drug development processes, and organizational structures. Over the last decade, wi...

    Thomas Severin, Solange Corriol-Rohou in Therapeutic Innovation & Regulatory Science (2020)

  5. Article

    Open Access

    Regulatory strategies for rare diseases under current global regulatory statutes: a discussion with stakeholders

    Rare or orphan diseases often are inherited and overwhelmingly affect children. Many of these diseases have no treatments, are incurable, and have a devastating impact on patients and their families. Regulator...

    Andrew E. Mulberg, Christina Bucci-Rechtweg in Orphanet Journal of Rare Diseases (2019)

  6. Article

    Open Access

    Subtrochanteric Fractures in Bisphosphonate-Naive Patients: Results from the HORIZON-Recurrent Fracture Trial

    Our purpose was to characterize the risks of osteoporosis-related subtrochanteric fractures in bisphosphonate-naive individuals. Baseline characteristics of patients enrolled in the HORIZON-Recurrent Fracture ...

    Jonathan D. Adachi, Kenneth Lyles, Steven Boonen in Calcified Tissue International (2011)