8 results match your criteria: "FDA Center for Drug Evaluation and Research (CDER)[Affiliation]"
Quantitative Structure-Activity Relationship Models to Predict Cardiac Adverse Effects.
Chem Res Toxicol
December 2024
FDA Center for Drug Evaluation and Research (CDER), Silver Spring, Maryland 20903, United States.
Article Synopsis
- Drug-induced cardiotoxicity is a major reason why drug candidates fail during development, making its evaluation critical in drug testing and regulatory review.
- The study analyzed FDA postmarket adverse events for 2002 drugs, categorizing cardiac toxicity-related terms into 12 relevant groups to create training sets for model development.
- Researchers used two commercial QSAR platforms to develop 12 predictive models, achieving up to 80% sensitivity and negative predictivity, which can improve the screening of potential cardiotoxic drugs in the development process.
Determining critical overlap concentration of polyethylene oxide to support excipient safety assessment of opioid products.
Int J Pharm
February 2023
U.S. Food and Drug Administration (FDA)/Center for Drug Evaluation and Research (CDER)/Office of Pharmaceutical Quality/Office of Testing and Research/Division of Product Quality Research, United States. Electronic address:
Intravenous administration of abuse-deterrent opioid products poses high safety risks, in part due to the presence of high molecular weight polymeric excipients. Previous in vivo studies in animal models have shown that the higher molecular weight (Mw) polymeric excipients like polyethylene oxide (PEO) were directly linked to such adverse responses as intravenous hemolysis and kidney damage. PEO polymers have been widely used in abuse-deterrent formulations (ADF) of opioid products, adding to concerns over the general safety of the opioid category due to the unknown safety risk from abuse via unintended routes.
View Article and Find Full Text PDFA top-down spectroscopic approach for correlating coating thickness distributions with the dissolution profiles of enterically coated pellets.
J Pharm Biomed Anal
February 2023
Food and Drug Administration (FDA)/Center for Drug Evaluation and Research (CDER)/Office of Pharmaceutical Quality (OPQ)/Office of Testing and Research (OTR)/Division of Complex Drug Analysis (DCDA), 645 S. Newstead Ave., St. Louis, MO 63110, USA. Electronic address:
Pharmaceutical dosage forms such as tablets and capsules are often coated with a functional polymer to modify the drug release. To obtain the drug release profiles, ensure quality control and predict in-vivo performance, dissolution studies are performed. However, dissolution tests are time-consuming, sample destructive and do not readily allow for at-line or in-line characterization.
View Article and Find Full Text PDFA review of pregnancy and lactation postmarketing studies required by the FDA.
Pharmacoepidemiol Drug Saf
March 2023
U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Office of New Drugs, Silver Spring, Maryland, USA.
Since pregnant and lactating women have historically been excluded from drug development trials, safety studies need to be conducted postapproval. This study evaluated FDA's Post Marketing Requirements for pregnancy and lactation studies from 2007 to 2020, and identified trends and potential future opportunities. The number of studies required to be conducted in the postmarketing setting was compared with the number of new drugs approved during the same time period.
View Article and Find Full Text PDFWhat can heart failure trialists learn from oncology trialists?
Eur Heart J
June 2021
Department of Medicine, University of Mississippi Medical Center, 2500 North State St, Jackson, MS, 39216, USA.
Globally, there has been little change in mortality rates from cardiovascular (CV) diseases or cancers over the past two decades (1997-2018). This is especially true for heart failure (HF) where 5-year mortality rates remain as high as 45-55%. In the same timeframe, the proportion of drug revenue, and regulatory drug approvals for cancer drugs, far out paces those for CV drugs.
View Article and Find Full Text PDFRaman mapping of fentanyl transdermal delivery systems with off-label modifications.
Analyst
February 2020
Food and Drug Administration (FDA)/Center for Drug Evaluation and Research (CDER)/Office of Pharmaceutical Quality (OPQ)/Office of Testing and Research (OTR)/Division of Pharmaceutical Analysis (DPA), St Louis, Missouri, USA.
Raman mapping is a powerful and emerging tool in characterization of pharmaceuticals and provides non-destructive chemical and structural identification with minimal sample preparation. One pharmaceutical form that is suitable but has not been studied in-depth with Raman mapping is transdermal delivery systems (TDS). TDS are dosage forms designed to deliver a therapeutically effective amount of active pharmaceutical ingredient (API) across a patient's skin.
View Article and Find Full Text PDFA systematic review of pregnancy exposure registries: examination of protocol-specified pregnancy outcomes, target sample size, and comparator selection.
Pharmacoepidemiol Drug Saf
February 2017
FDA CDER, Office of New Drugs, Silver Spring, MD, USA.
Purpose: Our study sought to systematically evaluate protocol-specified study methodology in prospective pregnancy exposure registries including pre-specified pregnancy outcomes, power calculations for sample size, and comparator group selection.
Methods: U.S.
Reports to FDA of fatal anaphylaxis associated with intravenous iron products.
Am J Hematol
December 2016
U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Office of Pharmacovigilance and Epidemiology, Silver Spring, Maryland.