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Drug approval prediction based on the discrepancy in gene perturbation effects between cells and humansResearch in context

• Authors : Minhyuk Park; Donghyo Kim; Inhae Kim

Subjects: Machine learning; Drug approval; Drug safety

• Source: EBioMedicine, Vol 94, Iss , Pp 104705- (2023)

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Advances on anticancer new drugs in China and the USA in 2020: from ongoing trial to drug approval

• Authors : Huiyao Huang; Huilei Miao; Jun Wang

Subjects: Neoplasms; Clinical trial; Drug

• Source: Journal of the National Cancer Center, Vol 1, Iss 4, Pp 147-152 (2021)

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Disease modification in osteoarthritis; pathways to drug approval

• Authors : Jeffrey N. Katz; Tuhina Neogi; Leigh F. Callahan

Subjects: Osteoarthritis; Structure-modifying therapy; Regulatory approval

• Source: Osteoarthritis and Cartilage Open, Vol 2, Iss 2, Pp 100059- (2020)

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A descriptive research: Exclusion from submitted clinical data package in the review process of new drug approval due to GCP violation in Japan

• Authors : Ryuta Asada; Kenichi Yoshimura; Kayo Hattori

Subjects: Medicine (General); R5-920

• Source: Contemporary Clinical Trials Communications, Vol 15, Iss , Pp - (2019)

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McClellan's FDA: boon to industry, consumers, or both? New FDA chief plans to speed drug approval and reduce costs.

• Authors : Ault A

Subjects: Administrative Personnel*; Drug Approval/Drug Approval/Drug Approval/*organization & administration ; United States Food and Drug Administration/United States Food and Drug Administration/United States Food and Drug Administration/*organization & administration

• Source: Lancet (London, England) [Lancet] 2003 Aug 02; Vol. 362 (9381), pp. 379-80.Publisher: Elsevier Country of Publication: England NLM ID: 2985213R Publication Model: Print Cited Medium: Internet

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From the European Medicines Agency to Project Orbis: new activities and challenges to facilitate UK oncology drug approval following Brexit

• Authors : Lythgoe, M; Krell, J; Bower, M

• Source: e160 ; e150

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Disease modification in osteoarthritis; pathways to drug approval

• Authors : Katz, JN; Neogi, T; Callahan, LF

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European Union scrambles to revise drug approval laws.

• Authors : Rogers A

Subjects: Drug Approval/Drug Approval/Drug Approval/*legislation & jurisprudence; European Union ; Humans

• Source: Lancet (London, England) [Lancet] 2003 Jun 14; Vol. 361 (9374), pp. 2056.Publisher: Elsevier Country of Publication: England NLM ID: 2985213R Publication Model: Print Cited Medium: Internet

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New drug approval process under scrutiny.

• Authors : Ross C

Subjects: Drug Approval/Drug Approval/Drug Approval/*legislation & jurisprudence; Drug Industry ; Japan

• Source: Lancet (London, England) [Lancet] 1994 Oct 15; Vol. 344 (8929), pp. 1075-6.Publisher: Elsevier Country of Publication: England NLM ID: 2985213R Publication Model: Print Cited Medium: Print

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Cancer drug indication approvals in China and the United States: a comparison of approval times and clinical benefit, 2001–2020Research in context

• Authors : Yuxuan Wei; Yichen Zhang; Ziyue Xu

Subjects: Drug approval timing; Overall survival; Anticancer drug

• Source: The Lancet Regional Health. Western Pacific, Vol 45, Iss , Pp 101055- (2024)

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