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Case Study: Two Examples of Successful Automation Integration at Altasciences for Pharmacokinetic Studies

Alta Sciences

Case Study: Two Examples of Successful Automation Integration at Altasciences for Pharmacokinetic Studies pmjackson Fri, 06/06/2025 - 09:01 By Martin Rougée, Optimization Scientist, Bioanalytical Operations Automation offers several advantages to any industry. Do you need a pharmacokinetic study?

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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. Clinical Pharmacology & Therapeutics , 111(3), 531538. Freyr Solutions.

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The rising impact of biomarkers in early clinical development

Drug Target Review

As pharmacological indicators, biomarkers overcome the static nature of traditional in vitro cellular studies by providing more dynamic models of pharmacokinetic processes that reflect active biological mechanisms. Trial design and statistical methods are also key to determining the utility and validity of biomarkers. Rodrigues AD.

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The future of CNS drug development: signs of real progress

Drug Target Review

Sig Transduct Target Ther 8 , 217 (2023). A board-certified toxicologist, she specialises in designing and managing nonclinical programmes across various modalities, including toxicology, pharmacokinetics, ADME and safety pharmacology. Adv Drug Deliv Rev. 2020;165-166:1-14. doi: 10.1016/j.addr.2019.11.009. 2019.11.009. PMID: 31790711.

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Elacestrant 

New Drug Approvals

2] Elacestrant was approved for medical use in the United States in January 2023, [1] [2] [5] [6] and in the European Union in September 2023. [3] 2] Elacestrant was approved for medical use in the United States in January 2023, [1] [2] [5] [6] and in the European Union in September 2023. [3] 8 February 2023.

FDA
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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.

FDA
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Gepirone

New Drug Approvals

4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] 4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] Archived from the original (PDF) on 28 September 2023. Retrieved 28 September 2023. 1986, ES 8606333.

FDA