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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. Understanding the key aspects of the regulatory framework and staying up-to-date with the latest developments is crucial for companies seeking to enter the Japanese market. References Tanaka, M., Freyr Solutions.

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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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Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

Food and Drug Administration (FDA) issued two guidance documents outlining the necessary evaluations during the clinical development of oligonucleotide therapeutics: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics and Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics .

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Altasciences’ Commitment to Supporting Pharma and Biotech With Comprehensive Bioanalytical Services

Alta Sciences

About Altasciences Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation , manufacturing, and analytical services.

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Vamorolone

New Drug Approvals

. “Population Pharmacokinetics of Vamorolone (VBP15) in Healthy Men and Boys With Duchenne Muscular Dystrophy” Journal of Clinical Pharmacology. “Exposure-Response Analysis of Vamorolone (VBP15) in Boys With Duchenne Muscular Dystrophy” Journal of Clinical Pharmacology. 59 (7): 979–988.

FDA
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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

“Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. . ^ Atarashi H, Kuruma A, Yashima M, Saitoh H, Ino T, Endoh Y, et al. August 2000). 68 (2): 14350. doi : 10.1067/mcp.2000.108733. 2000.108733. PMID 10976545.

FDA