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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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The Role of Scientific Expertise in Generic Drug Development

Drug Patent Watch

The Importance of Scientific Expertise Generic drug development involves a deep understanding of the scientific principles underlying drug development, including pharmacology, pharmacokinetics, and bioequivalence. Scientific experts in these fields are critical in ensuring that generic drugs are developed to meet the required standards.

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Drug-induced long QT syndrome: Concept and non-clinical models for predicting the onset of drug-induced torsade de pointes in patients in compliance with ICH E14/S7B guidance [Minireview]

ASPET

In 2022, ICH released E14/S7B Q&As (Stage 1), emphasizing a "double negative" nonclinical scenario for low-risk compounds. This review details the onset mechanisms of drug-induced TdP, including I Kr inhibition, pharmacokinetic factors, autonomic regulation and reduced repolarization reserve.

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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 62
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Metabolism of 2022 FDA approved small molecule drugs PART 2

Metabolite Tales Blog

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. Poster at ISSX/MDO 2022 Seattle meeting. [6] We hope it was a useful two-parter! Br J Pharmacol.

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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.