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Academic Journal

The evolutionary safety of mutagenic drugs should be assessed before drug approval.

  • Authors : Lobinska G; Department of Molecular Genetics, Weizmann Institute of Science, Rehovot, Israel.; Tretyachenko V

Subjects: Drug Approval* ; Mutagens*/Mutagens*/Mutagens*/toxicity; Mutagenesis

  • Source: PLoS biology [PLoS Biol] 2024 Mar 15; Vol. 22 (3), pp. e3002570. Date of Electronic Publication: 2024 Mar 15 (Print Publication: 2024).Publisher: Public Library of Science Country of Publication: United States NLM ID: 101183755 Publication Model: eCollection Cited Medium: Internet

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Report

Critical insights into the evolving drug-approval process in China.

  • Authors : Nikanjam M; Division of Hematology-Oncology, University of California San Diego, La Jolla, California, USA.; Kurzrock R

Subjects: Drug Approval*; Humans ; United States

  • Source: Cancer [Cancer] 2024 Mar 01; Vol. 130 (5), pp. 665-667. Date of Electronic Publication: 2024 Jan 02.Publisher: Wiley Country of Publication: United States NLM ID: 0374236 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-0142

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Periodical

COLD COMFORT.

Subjects: FREEDOM of Information Act (U.S.); DRUG approval

  • Source: Scientific American. Mar2024, Vol. 330 Issue 3, p64-69. 6p. 2 Color Photographs, 1 Diagram.

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Academic Journal

Drug approval delays in hematologic malignancies between Europe and the US and between Japan and the US: a clinical perspective.

  • Authors : Matsuda K; Department of Hematology and Oncology, JR Tokyo General Hospital, Shibuya-ku, Japan.; Nagai S

Subjects: Drug Approval* ; Hematologic Neoplasms*/Hematologic Neoplasms*/Hematologic Neoplasms*/drug therapy; Humans

  • Source: Japanese journal of clinical oncology [Jpn J Clin Oncol] 2023 Dec 07; Vol. 53 (12), pp. 1125-1129.Publisher: Oxford University Press Country of Publication: England NLM ID: 0313225 Publication Model: Print Cited Medium: Internet ISSN:

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Report

Bayesian analysis of real-world data as evidence for drug approval: Remembering Sir Michael Rawlins.

  • Authors : Szigeti B; Centre for Psychedelic Research, Division of Psychiatry, Imperial College London, London, UK.; Phillips LD

Subjects: Drug Approval* ; State Medicine*; Humans

  • Source: British journal of clinical pharmacology [Br J Clin Pharmacol] 2023 Sep; Vol. 89 (9), pp. 2646-2648. Date of Electronic Publication: 2023 Jul 17.Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 7503323 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Drug approval prediction based on the discrepancy in gene perturbation effects between cells and humans.

  • Authors : Park M; Department of Life Sciences, Pohang University of Science and Technology, Pohang, South Korea.; Kim D

Subjects: Drug Approval* ; Drug-Related Side Effects and Adverse Reactions*; Humans

  • Source: EBioMedicine [EBioMedicine] 2023 Aug; Vol. 94, pp. 104705. Date of Electronic Publication: 2023 Jul 13.Publisher: Elsevier B.V Country of Publication: Netherlands NLM ID: 101647039 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Editorial & Opinion

Collateral damage from accelerated drug approval.

Subjects: Drug Approval*/Drug Approval*/Drug Approval*/legislation & jurisprudence ; Acceleration*; United States

  • Source: Nature [Nature] 2023 Oct; Vol. 622 (7982), pp. 242.Publisher: Nature Publishing Group Country of Publication: England NLM ID: 0410462 Publication Model: Print Cited Medium: Internet ISSN:

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Academic Journal

Accelerated drug approval: Meeting the ethical yardstick.

Subjects: Drug Approval* ; Morals*; Humans

  • Source: Bioethics [Bioethics] 2023 Sep; Vol. 37 (7), pp. 647-655. Date of Electronic Publication: 2023 Jun 21.Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 8704792 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Analysis of safety specifications in risk management plan at the time of drug approval and addition of clinically significant adverse reactions in the package insert post-approval in Japan.

  • Authors : Saito R; Division of Social Pharmacy and Regulatory Science, Showa Pharmaceutical University, Machida-shi, Tokyo, Japan.; Miyazaki S

Subjects: Drug Approval* ; Drug-Related Side Effects and Adverse Reactions*/Drug-Related Side Effects and Adverse Reactions*/Drug-Related Side Effects and Adverse Reactions*/epidemiology ; Drug-Related Side Effects and Adverse Reactions*/Drug-Related Side Effects and Adverse Reactions*/Drug-Related Side Effects and Adverse Reactions*/prevention & control

  • Source: Pharmacology research & perspectives [Pharmacol Res Perspect] 2023 Aug; Vol. 11 (4), pp. e01110.Publisher: John Wiley & Sons Ltd, British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics Country of Publication: United States

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Editorial & Opinion

Clinical trials: Japan's opt-out policy raises risks of adverse drug responses.

Subjects: Drug Approval*/Drug Approval*/Drug Approval*/legislation & jurisprudence ; Drug Approval*/Drug Approval*/Drug Approval*/methods ; Drug-Related Side Effects and Adverse Reactions*

  • Source: Nature [Nature] 2024 Feb; Vol. 626 (7998), pp. 261.Publisher: Nature Publishing Group Country of Publication: England NLM ID: 0410462 Publication Model: Print Cited Medium: Internet ISSN:

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  • 1-10 of  363,609 results for ""Drug Approval""