A decade of FDA-approved drugs (2010–2019): trends and future directions
A total of 378 novel drugs and 27 biosimilars approved by the US Food and Drug
Administration (FDA) between 2010 and 2019 were evaluated according to approval …
Administration (FDA) between 2010 and 2019 were evaluated according to approval …
The concept of an ideal antibiotic: implications for drug design
M Gajdács - Molecules, 2019 - mdpi.com
The emergence and spread of antibiotic-resistant pathogens is a major public health issue,
which requires global action of an intersectoral nature. Multidrug-resistant (MDR) pathogens …
which requires global action of an intersectoral nature. Multidrug-resistant (MDR) pathogens …
Estimated research and development investment needed to bring a new medicine to market, 2009-2018
Importance The mean cost of developing a new drug has been the subject of debate, with
recent estimates ranging from $314 million to $2.8 billion. Objective To estimate the …
recent estimates ranging from $314 million to $2.8 billion. Objective To estimate the …
FDA approval and regulation of pharmaceuticals, 1983-2018
Importance US law requires testing of new drugs before approval to ensure that they provide
a well-defined benefit that is commensurate with their risks. A major challenge for the US …
a well-defined benefit that is commensurate with their risks. A major challenge for the US …
The application of in silico drug-likeness predictions in pharmaceutical research
The concept of drug-likeness, established from the analyses of the physiochemical
properties or/and structural features of existing small organic drugs or/and drug candidates …
properties or/and structural features of existing small organic drugs or/and drug candidates …
Antibiotic resistance: from the bench to patients
M Gajdács, F Albericio - Antibiotics, 2019 - mdpi.com
The discovery and subsequent clinical introduction of antibiotics is one of the most important
game-changers in the history of medicine [1]. These drugs have saved millions of lives from …
game-changers in the history of medicine [1]. These drugs have saved millions of lives from …
Characteristics of preapproval and postapproval studies for drugs granted accelerated approval by the US Food and Drug Administration
Importance Drugs treating serious or life-threatening conditions can receive US Food and
Drug Administration (FDA) accelerated approval based on showing an effect in surrogate …
Drug Administration (FDA) accelerated approval based on showing an effect in surrogate …
Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study
Objective To evaluate the use of special expedited development and review pathways at the
US Food and Drug Administration over the past two decades. Design Cohort study. Setting …
US Food and Drug Administration over the past two decades. Design Cohort study. Setting …
Intravenous immune globulin for statin-triggered autoimmune myopathy
AL Mammen, E Tiniakou - New England Journal of Medicine, 2015 - Mass Medical Soc
Although most statin-related myopathy is self-limited, in rare cases statins trigger
autoimmune myopathy, which requires control with immunosuppressive therapy. Three …
autoimmune myopathy, which requires control with immunosuppressive therapy. Three …
Characterization of resistance in gram-negative urinary isolates using existing and novel indicators of clinical relevance: a 10-year data analysis
Classical resistance classifications (multidrug resistance [MDR], extensive drug resistance
[XDR], pan-drug resistance [PDR]) are very useful for epidemiological purposes, however …
[XDR], pan-drug resistance [PDR]) are very useful for epidemiological purposes, however …