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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

Clinical Pharmacology & Therapeutics , 111(3), 531538. Journal of Clinical Pharmacology , 51(3), 531538. References Tanaka, M., Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis. Freyr Solutions. Regulatory System on Generic Drugs in Japan.

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The rising impact of biomarkers in early clinical development

Drug Target Review

Clinical Pharmacology and Therapeutics. Clinical Pharmacology and Therapeutics. Clarke trained in medicineand immunology at University College London and has had a long-standing interest in the utilisation of biomarker strategies in early clinical development. Rodrigues AD. 113:9861002.

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Vamorolone

New Drug Approvals

10] Vamorolone was approved for medical use in the United States in October 2023, [11] [10] and in the European Union in December 2023. [2] Vamorolone was approved by the FDA in October 2023 for the management of DMD in patients ≥2 years of age. 2] Vamorolone was approved for medical use in the European Union in December 2023.

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Gamcemetinib

New Drug Approvals

Gamcemetinib CAS 1887069-10-4 CC-99677 , OS2IR8TV1O Molecular Weight 469.94 nM) and cell based assays ( EC 50 =89 nM).

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Landiolol

New Drug Approvals

Landiolol was approved for medical use in Japan in 2002, [10] [11] in Canada in November 2023, [1] and in the United States in November 2024. [12] 20 November 2023. This has a positive impact on the treatment of patients when reduction of heart rate without decrease in arterial blood pressure is desired. [9] 2 July 2024. August 2000).

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Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval?

Fierce BioTech

Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval? pesurya Thu, 10/26/2023 - 14:05 Tue, 12/05/2023 - 11:00 Resource Type Webinar Julie Bullock, PharmD Krithika Shetty, PhD Blaire Osborn, Ph.D. png Listing Introduction Clinical pharmacology information comprises more than 50% of a drug label.

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Antibody Drug Conjugates: windows of opportunity

Drug Target Review

2022 Nov 14 [cited 2023 Apr 6];40(11):1255–63. Translational and Clinical Pharmacology [Internet]. 2022 [cited 2023 Feb 10];30(2):71. Clinical Pharmacology & Therapeutics. The therapeutic window of antibody drug conjugates: A dogma in need of revision. Cancer Cell [Internet]. 2021 Jul 8;110(5):1216–30.