Results 131 to 140 of about 5,545,002 (288)

Current philosophical perspectives on drug approval in the real world

Journal of Causal Inference
The evidence-based medicine approach to causal medical inference is the dominant account among medical methodologists. Competing approaches originating in the philosophy of medicine seek to challenge this account.
Landes Jürgen, Auker-Howlett Daniel J.
doaj   +1 more source

Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway

Journal of Pharmaceutical Policy and Practice
Background Withdrawals of drug indications may reveal potential inadequacies in the regulatory approval processes of new drugs. Understanding potential weaknesses of the regulatory approval process is paramount given the increasing use of expedited ...
Mahnum Shahzad, Huseyin Naci, Katharine M. Esselen, Joseph A. Dottino, Anita K. Wagner   +4 more
doaj   +1 more source

I-ACT for Children: helping close the gap in drug approval for adults and children. [PDF]

Pediatr Res, 2023
Coppes MJ, Jackson C, Connor EM.
europepmc   +1 more source

Anticancer Drug Development: Preclinical Screening, Clinical Trials and Approval [PDF]

, 2004
David L. Selwood
openalex   +1 more source

Implications of Evolving Disease Classification for Drug Approval in Juvenile Idiopathic Arthritis. [PDF]

Paediatr Drugs, 2022
Case SM, Nigrovic PA.
europepmc   +1 more source

U.S. Food and Drug Administration Approval of AmBisome (Liposomal Amphotericin B) for Treatment of Visceral Leishmaniasis

, 1999
Andrea Meyerhoff
openalex   +1 more source

'Fast-track' drug approvals hit speed bumps in Japan [PDF]

, 2004
Douglas Sipp
openalex   +1 more source

Erratum: Anticancer drug development: preclinical screening, clinical trials and approval [PDF]

, 2004
B A Teicher, David L. Selwood, Paul A. Andrews   +2 more
openalex   +1 more source

Regulatory Disparities Between US Accelerated Approval and Japanese Authorization of Oncology Drugs: An Analysis of Evidence Quality

Clinical and Translational Science
While the accelerated approval (AA) program in the United States expedites the availability of drugs based on preliminary evidence to fulfill unmet medical needs, it has also raised significant concerns, including a lack of robust evidence of efficacy ...
Maho Iwata, Anju Murayama
doaj   +1 more source

Accelerated Approval Seen as Triumph and Roadblock for Cancer Drugs [PDF]

, 2004
Elizabeth J. Susman
openalex   +1 more source