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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

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. References Tanaka, M., Clinical Pharmacology & Therapeutics , 111(3), 531538.

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A spatial approach to understanding drug dynamics using mass spectrometry imaging

Drug Target Review

Unlike traditional pharmacokinetic (PK) studies that rely on plasma measurements alone, MSI, when combined with traditional histology, enables spatial mapping of drug distribution, metabolism and target engagement. Release 2022, 352 , 199–210. For instance, Cheng et al. 4 Similarly, Groseclose et al. Mass Spectrom.

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Time for change: non-human primates in drug research

Drug Target Review

Their unique suitability has made them valuable for evaluating pharmacokinetics, toxicology and safety in drug candidates before human clinical trials. FDA announces plan to phase out animal testing requirement for monoclonal antibodies and other drugs. Bailey J, et al. Trends in Non-Human Primate Use for Research and Testing.

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Contezolid

New Drug Approvals

In a pharmacokinetic (PK) rat model, the exposure of active drug CZD after IV administration of the prodrug CZA was similar to or higher than that from the IV administration of CZD. Zhao X, Huang H, Yuan H, Yuan Z, Zhang Y (May 2022). July 2022). CZA rapidly converts into the active drug CZD in vivo. 57 (11): 4487–4497.

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Elacestrant 

New Drug Approvals

1] [8] Pharmacokinetics Elacestrant has an oral bioavailability of approximately 10%. [1] Lloyd MR, Wander SA, Hamilton E, Razavi P, Bardia A (2022). 1] Additionally, elacestrant is a selective estrogen receptor degrader (SERD), meaning it induces the degradation of ER. [1] 21 September 2023. Retrieved 22 September 2023.

FDA
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Vamorolone

New Drug Approvals

79 (2022) 1005–1014. [71] 79 (2022)1005–1014 Bioorg. 16] Population pharmacokinetics (PK) of vamorolone was shown to fit to a 1-compartment model with zero-order absorption, with both adult men and young boys showing dose-linearity of PK parameters for the doses examined, and no accumulation of the drug during daily dosing. .

FDA
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Resigratinib

New Drug Approvals

The safety, tolerability, pharmacokinetics, and preliminary efficacy of KIN-3248 are currently being evaluated in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations. February 2022). Wang Z, Anderson KS (2022). 40 (4_suppl): 461. doi : 10.1200/JCO.2022.40.4_suppl.461. 2022.40.4_suppl.461. doi : 10.1200/JCO.2023.41.4_suppl.TPS637.