Drug Patent Watch

DECEMBER 30, 2024

Key Requirements for Generic Drug Approval Bioequivalence Studies : The PMDA requires bioequivalence studies to ensure that the generic drug is equivalent to the RLD in terms of its pharmacokinetic and pharmacodynamic properties. Pharmaceutical Regulations in Japan 2020. Retrieved from [link] Pharmaceuticals and Medical Devices Agency.

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Drug Development Clinical Pharmacology Clinical Trials Pharmaceutical Companies 52

Drug Target Review

NOVEMBER 1, 2023

2,8-10 However, the number of compounds with satisfying pharmacokinetic parameters (PKD) are limited, with most unable to cross the blood-brain barrier or go sufficiently deep into a malignant tumour. 2011 Jul 14;54(13):4619–26. Recently, our laboratory discovered a potent partial inhibition of ATX by cannabinoids in a nanomolar range.

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Clinical Trials Trials Small Molecule Disease 134

Drug Target Review

OCTOBER 3, 2024

These assays may include pharmacokinetic (PK) assays, which provide information on the drug’s properties, and immunogenicity assays for the detection of anti-drug antibodies (ADA), which can lead to adverse events and reduced efficacy. 2011 Oct 1;413(1):261–78. Journal of Molecular Biology. Harth S, Ten Haaf A, Loew C, et al.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

New Drug Approvals

SEPTEMBER 13, 2024

14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] 2] It first appeared in the scientific literature in 2010 or 2011. [16] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] 2] It first appeared in the scientific literature in 2010 or 2011. [16] December 2011). nM vs. 24.0

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Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

New Drug Approvals

JANUARY 13, 2023

January 2011). “SC-52458, an orally active angiotensin II-receptor antagonist: inhibition of blood pressure response to angiotensin II challenges and pharmacokinetics in normal volunteers” Journal of Cardiovascular Pharmacology. Forasartan has a high affinity for the AT 1 receptor ( IC50 =2.9 +/- 0.1nM). [12] PMID 9156352.

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Pharmacokinetics Drugs Production Research 52

Metabolite Tales Blog

DECEMBER 13, 2023

Sanna Kaivosaari, Moshe Finel & Mikko Koskinen (2011). 8(2):3640-3648; [link] [11] Pharmacokinetics of the Multi-kinase Inhibitor Pexidartinib: Mass Balance and Dose Proportionality. Drug Metabolism and Disposition 42 (4) 650-664; [link]. [2] Xenobiotica, 41:8, 652-669; [link]. [3] J Pharm Biomed Anal. Oncotarget. Greenberg, J.,

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Small Molecule Metabolic Stability Treatment Pharmacokinetics 59

Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. When looking at several pharmacokinetic studies, the FDA found that the 10 mg oral dose of phenylephrine has a very low bioavailability of less than 1% and, subsequently, low systemic alpha-1 adrenergic activity.

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Science FDA Clinical Trials Clinical Pharmacology 40