Zobrazeno 1 - 10
of 21
pro vyhledávání: '"Irwin G. Martin"'
Publikováno v:
Therapeutic innovationregulatory science. 54(4)
FDA had been criticized for its slow review of new drugs. Critics complained of a “drug lag” from which US patients suffered when compared to Europeans. Since the advent of PDUFA, however, the FDA has demonstrated a possible slight advantage in r
Publikováno v:
Therapeutic innovationregulatory science. 47(2)
The US Congress and the US Food and Drug Administration encouraged studies in children so that the labeling information about pediatric use could be updated for pharmaceutical products. Pediatricians receive this updated labeling information through
Autor:
Irwin G. Martin, Gopal Reddy Palvatla
Publikováno v:
Therapeutic innovationregulatory science. 49(1)
Fentora (fentanyl citrate) is an analgesic opioid used in the management of breakthrough pain in adult cancer patients. Numerous reports of medication errors had been reported since the product’s launch in 2006, 74% of which were prescribing errors
Publikováno v:
Therapeutic innovationregulatory science. 49(6)
It is widely acknowledged that patient recruitment is a significant challenge and represents one of the primary reasons for drug development delays. Data from the Center for Information and Study on Clinical Research Participation (CISCRP) “Percept
Publikováno v:
Journal of AIDS & Clinical Research. 8
Objective: To identify the impact of professional knowledge and education on willingness to participate in clinical trials. Methods: The study was conducted during January 2017 at Eastern Michigan University, Michigan, United States. It was a cross-s
Autor:
Sowmya Mallela, Irwin G. Martin
Publikováno v:
Therapeutic Innovation & Regulatory Science. 49:33-35
The incidence and mortality rates of the ten most prevalent cancers types in the US were compared with the National Cancer Institute's funding of clinical studies in 2012. Additionally, a sampling of print and broadcast media coverage of these ten ca
Publikováno v:
Therapeutic Innovation & Regulatory Science. 47:90-94
The number of clinical research investigators that the US Food and Drug Administration has disqualified or totally restricted has been increasing since 1964. In addition, several public polls and surveys indicate a major dilemma in clinical trial par
Publikováno v:
Drug Information Journal. 46:694-700
Some drugs have been removed from the market once it had been determined that their risks outweighed their benefits. Withdrawals negatively impact patients using the drugs as well the pharmaceutical companies who devoted tremendous resources to resea
Autor:
Annet Zakaryan, Irwin G. Martin
Publikováno v:
Drug Information Journal. 46:532-544
This article outlines the importance of herbal dietary supplements regulation by providing a brief overview of history of supplement regulation in the US with emphasis placed on passage of the 1994...
Publikováno v:
Drug Information Journal. 46:313-319
Subject retention is one of the key factors that determine success of a clinical trial. Many researchers have focused on the issue of recruitment, and few have focused on retention. Subjects discontinue from clinical trials for variety of reasons. So