2017 Pharmacokinetics Regulations 
Drug Target Review
JULY 7, 2025
Their unique suitability has made them valuable for evaluating pharmacokinetics, toxicology and safety in drug candidates before human clinical trials. 3-5 These layers of regulation, while essential for animal welfare, make NHP-based studies complex, expensive and time-consuming. Are we nearing a post-NHP future? Front Pharmacol.
New Drug Approvals
JULY 18, 2025
22] In the same month, China’s drug regulator (NMPA) decided to fast-track the approval process, labelling it a first-in-class medication. [14] In July 2022, China’s drug regulator granted conditional approval for it to be used to treat COVID-19, following a local phase III trial. [6] July 2017). 98 : 379–386.
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Drug Target Review
SEPTEMBER 19, 2023
This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938. To this end, the FDA’s newly created iSTAND initiative drives the path toward regulatory approval for devices like organ-on-chips.
The Pharma Data
JANUARY 19, 2021
The secondary objective is to assess the pharmacokinetic profile of SAD and MAD of ALS-4 administered orally to healthy subjects. This announcement is not a prospectus within the meaning of the Regulation (EU) n°2017/1129 of 14 June 2017 as amended by Regulations Delegated (EU) n°2019/980 of 14 March 2019 and n°2019/979 of 14 March 2019.
The Pharma Data
DECEMBER 20, 2020
Pending Health Canada’s approval, the Phase 1 trial is designed to test the safety, tolerability and pharmacokinetics of ALS-4 in healthy volunteers. The secondary objective is to assess the pharmacokinetic profile of SAD and MAD of ALS-4 administered orally to healthy subjects. About ALS-4.
New Drug Approvals
OCTOBER 24, 2023
“The Selective Sphingosine 1-Phosphate Receptor Modulator Etrasimod Regulates Lymphocyte Trafficking and Alleviates Experimental Colitis” J Pharmacol Exp Ther. Peyrin-Biroulet L, Christopher R, Behan D, Lassen C (May 2017). Retrieved 13 October 2023. ^ [link] ^ World Health Organization (2017). 369 (3): 311–317.
Metabolite Tales Blog
DECEMBER 13, 2023
UGT1A enzymes were shown to be down-regulated in several cancers, and mutations in UGT genes enhance the risk of bladder cancer in smokers [10]. 8(2):3640-3648; [link] [11] Pharmacokinetics of the Multi-kinase Inhibitor Pexidartinib: Mass Balance and Dose Proportionality. A route to be avoided or a desired route of metabolism?
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