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Published in 2019 at "JAMA internal medicine"
DOI: 10.1001/jamainternmed.2019.1213
Abstract: This cross-sectional study reviews New Drug Applications for new molecular entities and Biologics License Applications for new and biosimilar biological products submitted to the US Food and Drug Administration to assess how frequently applicants disclose…
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Keywords:
drug;
drug administration;
food drug;
new drug ... See more keywords
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Published in 2022 at "JAMA Network Open"
DOI: 10.1001/jamanetworkopen.2022.36149
Abstract: Key Points Question Are older adults adequately represented in clinical trials for new drug evaluation? Findings In this cross-sectional study, adults in the oldest age groups above age 75 years or in some therapeutic areas…
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Keywords:
older adults;
clinical trials;
new drug;
trials new ... See more keywords
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Published in 2021 at "Cancer Medicine"
DOI: 10.1002/cam4.3791
Abstract: Single patient Investigational New Drug (IND) applications are one mechanism through which experimental therapies are accessed for children with cancer. The landscape of use, outcomes, and toxicity from single patient INDs remains unknown in pediatric…
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Keywords:
patient investigational;
single patient;
new drug;
investigational new ... See more keywords
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Published in 2020 at "Clinical Pharmacology and Therapeutics"
DOI: 10.1002/cpt.2080
Abstract: The Pharmaceuticals and Medical Devices Agency (PMDA) has approved hundreds of new drugs in recent years. We retrospectively analyzed the new drugs approved in Japan from 2008 to 2019, and identify the first‐in‐world approvals and…
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Keywords:
drug lag;
new drug;
drug;
japan ... See more keywords
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Published in 2021 at "Clinical pharmacology and therapeutics"
DOI: 10.1002/cpt.2491
Abstract: Leveraging limited clinical and non-clinical data through modeling approaches facilitates new drug development and regulatory decision making amid the Coronavirus Disease 2019 (COVID-19) pandemic. Model-informed drug development (MIDD) is an essential tool to integrate those…
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Keywords:
drug development;
model informed;
new drug;
drug ... See more keywords
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Published in 2023 at "Health economics"
DOI: 10.1002/hec.4650
Abstract: When drugs enter the market, physicians' prescribing behavior plays a crucial role in the diffusion process. Although regulations to foster economically efficient prescribing exist, physicians have some degree of freedom in choosing medication and are…
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Keywords:
diffusion new;
impact patient;
new drug;
patient pathways ... See more keywords
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Published in 2023 at "Medicinal research reviews"
DOI: 10.1002/med.21976
Abstract: The U.S. Food and Drug Administration has approved a total of 37 new drugs in 2022, which are composed of 20 chemical entities and 17 biologics. In particular, 20 chemical entities, including 17 small molecule…
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Keywords:
new drug;
synthesis;
mechanism action;
chemical ... See more keywords
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Published in 2018 at "Pharmacoepidemiology and Drug Safety"
DOI: 10.1002/pds.4351
Abstract: Greater than 50% of drugs lack pediatric labeling information, resulting in widespread “off‐label” use in children. To increase pediatric prescribing information, the Pediatric Research Equity Act (PREA) was passed in 2003, requiring new drug applications…
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Keywords:
information;
drug information;
information available;
new drug ... See more keywords
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Published in 2020 at "Analytical and Bioanalytical Chemistry"
DOI: 10.1007/s00216-020-02498-8
Abstract: The analysis of complex mixtures of closely related species is quickly becoming a bottleneck in the development of new drug substances, reflecting the ever-increasing complexity of both fundamental biology and the therapeutics used to treat…
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Keywords:
chromatography;
analysis;
new drug;
drug substances ... See more keywords
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Published in 2020 at "Drugs"
DOI: 10.1007/s40265-020-01451-4
Abstract: 50 years ago there was a plethora of new drug introductions, but a dearth of sources of reliable, balanced information to aid rational prescribing decisions. Drugs was introduced in 1971 to meet this need, as…
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Keywords:
literature;
source;
new drug;
drug ... See more keywords
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Published in 2020 at "Addictive behaviors"
DOI: 10.1016/j.addbeh.2020.106679
Abstract: BACKGROUND Understanding adolescent drug use mechanisms is critical for drug use prevention. Although some theories such as the gateway theory suggest that drug users gradually transition into using more addictive drugs, there is no consensus…
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Keywords:
initiation;
use;
new drug;
drug use ... See more keywords