Results 131 to 140 of about 2,558,154 (306)
Do Off-Label Drug Practices Argue Against FDA Efficacy Requirements? Testing an Argument by Structured Conversations with Experts [PDF]
The Food, Drug and Cosmetics Act of 1938 with amendments in 1962 is inconsistent regarding FDA certification of a drug’s efficacy. The act requires efficacy certification for the drug’s initial (“on-label”) uses, but does not require certification before
Klein, Daniel, Tabarrok, Alexander
core
ChemFoodChem, EarlyView.This research showed that sausage reformulation preserves high essential amino acid and branched‐chain amino acid content, as well as increasing free amino acids (FAA) related to umami flavor and health‐promoting components such as GABA in the products.
Albert Gashi +4 more
wiley +1 more source
Selective Non‐Catalytic Reduction of NOx in the Exhaust Gas of Small Wood Gasification Boilers
Chemie Ingenieur Technik, EarlyView.Kinetic studies of the SNCR reaction were conducted to investigate NOx reduction in the exhaust gas of small‐scale wood gasification boilers. Both the experimental results and the derived global kinetic model indicate that SNCR can achieve a significant reduction in NOx emissions under typical operating conditions. ABSTRACT The gas‐phase reaction of NO
Alexander Groß, Sven Kureti
wiley +1 more source
Multisource drug policies in Latin America: survey of 10 countries
Bulletin of the World Health Organization, 2005 Essential drug lists and generic drug policies have been promoted as strategies to improve access to pharmaceuticals and control their rapidly escalating costs.
Homedes Núria, Ugalde Antonio
doaj
Pediatric Developmental Safety Assessment: Are We Ready for the Next Thalidomide?
Clinical Pharmacology &Therapeutics, EarlyView.Pediatric drug development has achieved remarkable success in the last 20 years with over 1,000 products studied in pediatric patients. This success has been driven in part by an increased understanding of pediatric disease processes. The aspect that has been largely overlooked is the potential adverse effect of new drugs on pediatric developmental ...
Gilbert J. Burckart +6 more
wiley +1 more source
Drug policy reform in South America: Towards a Multiaxial Model of Preventive Regulation
Relaciones Internacionales, 2016 Since the creation of the Union of South American Nations (UNASUR) in 2008, its members evidence an endogenous contradiction in relation to the illegal drug issue.
Nicolás Matías COMINI
doaj
Digital Transformation of Medicines Regulation in Africa—Perspectives from a Stakeholder Convening
Clinical Pharmacology &Therapeutics, EarlyView.Regulatory authorities worldwide are developing strategies to integrate artificial intelligence (AI) into the lifecycle of health products, technologies, and medicines. While regulators share goals of improving efficiency, strengthening decision‐making, and protecting public health, their approaches differ according to institutional structures ...
Christelna Reyneke +12 more
wiley +1 more source
Clinical Pharmacology &Therapeutics, EarlyView.Regulatory bodies play a central role in providing guidance that enables safe and effective use of artificial intelligence tools in medicine development and evaluation. Regulators can also act as catalysts for regulatory science research. To inform these efforts, a European‐wide survey was conducted to solicit stakeholder perspectives on the priority ...
Luis C. Pinheiro +9 more
wiley +1 more source
Thirty Years of Orphan Drug Legislation and the Development of Drugs to Treat Rare Seizure Conditions: A Cross Sectional Analysis. [PDF]
PLoS One, 2016 Döring JH +3 more
europepmc +1 more source
Clinical Pharmacology &Therapeutics, EarlyView.Pregnancy‐associated breast cancer (PrBC) presents therapeutic challenges. Understanding maternal–fetal safety of systemic anticancer therapies is critical. We performed a case/non‐case disproportionality analysis using the WHO global pharmacovigilance database up to January 2024, to evaluate maternal–fetal outcomes associated with breast cancer (BC ...
Rayan Kabirian +12 more
wiley +1 more source