Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10427936 | PMC |
| http://dx.doi.org/10.1001/jamanetworkopen.2023.29006 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Cell-Based Assays to Detect Innate Immune Response Modulating Impurities: Application to Biosimilar Insulin.
AAPS J
December 2024
Laboratory of Immunology, Office of Pharmaceutical Quality Research Division-IV, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA.
Characterizing and mitigating factors that impact product immunogenicity can aid in risk assessment and/or managing risk following manufacturing changes. For follow-on products that have the same indication, patient population, and active product ingredient, the residual immunogenicity risk resides predominantly on differences in product and process related impurities. Characterizing differences in innate immune modulating impurities (IIRMI), which could act as adjuvants by activating local antigen presenting cells (APCs), can inform the immunogenicity risk assessment potentially reducing the need for clinical trials.
View Article and Find Full Text PDFTugging the Foley catheter balloon every three hours in induction of labor after one previous cesarean: a randomized controlled trial.
Am J Obstet Gynecol MFM
December 2024
Faculty of Medicine, Department of Obstetrics and Gynecology, University of Malaya, Jalan Profesor Diraja Ungku Aziz, Kuala Lumpur, Malaysia. Electronic address:
Article Synopsis
- Induction of labor after a previous cesarean poses high risks, and using a Foley balloon for mechanical ripening is preferred over prostaglandins due to lower risk of complications like uterine rupture.
- This study aims to assess the effects of tugging the Foley balloon every three hours on the time from induction to delivery and overall patient satisfaction compared to standard care without tugging.
- Conducted as a randomized controlled trial in Malaysia from April 2023 to March 2024, 126 participants were recruited, and outcomes measured included the time interval from balloon insertion to delivery and participants' satisfaction, with expectations of a significant reduction in delivery time and improvement in satisfaction scores.
Patient experiences with prenatal cell-free DNA screening in a safety net setting.
Prenat Diagn
April 2024
Biomedical Ethics Research Program, Mayo Clinic, Rochester, Minnesota, USA.
Objectives: Thirty-five states, including Florida, now cover cell-free DNA (cfDNA) screening of fetuses for all pregnant patients enrolled in state public insurance programs. We interviewed Black and Hispanic obstetric patients at a safety net clinic in Florida shortly after the state rolled out cfDNA as a first-tier screening method for publicly insured patients.
Methods: Black and Hispanic patients receiving prenatal care from a prenatal or maternal fetal medicine clinic at a federally qualified health center in Jacksonville, FL were invited to participate in a qualitative interview in English or Spanish to explore experiences and perceptions of prenatal cfDNA screening.
Follow-On Indications for Orphan Drugs Related to the Inflation Reduction Act.
JAMA Netw Open
August 2023
Center for the Evaluation of Value and Risk in Health, Tufts Medical Center, Boston, Massachusetts.
A Detailed Analysis of the Past 20 Years of US FDA-Approved Prescription to Over-the-Counter Switches.
Ther Innov Regul Sci
September 2023
Haleon, 184 Liberty Corner Rd, Warren, NJ, 07059-6796, USA.
Objectives: This evaluation assesses the quantity, uniqueness, and innovative nature of the past 20 years of Rx-to-OTC (RTO) switches, where a current prescription (Rx) product is reclassified for over-the-counter (OTC) status. Broadening access to more OTC drugs with well-established safety and efficacy could help to reduce healthcare expenditure and address public health challenges.
Methods: The FDA-maintained RTO switch list website was accessed to generate the primary dataset.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!