Clinical Pharmacology MedUni Vienna’s Post

Read our new article by Fenna Sille and myself: Metabolomics in Preclinical Drug Safety Assessment: Current Status and Future Trends In the journal Metabolites.  https://lnkd.in/gw3rE3bm #Metabolomics #drugdevelopment #toxicology #CAAT #Exposome #JohnsHopkins #alternativemethods #3Rs

Around 88% of new drugs fail to make it through clinical trials. This is costly and time-consuming, so it makes sense to stack the odds in your favour and only advance your candidate to clinical trials when you know it has a high chance of success. Pre-clinical toxicology studies are fundamental in making informed, evidence-based decisions about your candidate’s readiness for clinical trials. At Hoeford we help to bring new drugs from concept to market with integrated preclinical toxicology testing programmes. Click here to speak to a member of our team about how we can help your new drug to be one of the 12% https://bit.ly/42YVDsI #drugcandidate #drugdevelopment #toxicology #preclinicalresearch

Hi everyone, FDA recently released draft guidance for data integrity for invivo BA and BE studies. >>Purpose: To provide recommendations to applicants and testing site management on achieving and maintaining data integrity for the clinical and bioanalytical portions of bioavailability (BA) and bioequivalence (BE) studies submitted in support of INDs, NDAs, BLAs, and ANDAs. Recommended to be used for other studies including in vitro and pharmacology and toxicology studies. #FDA #Guidance #BA #BE #dataintegrity #Pharma #invivo #invitro #pharmacology #toxicology #regulatory

Hot off the press -- a new article from CAAT Director, Thomas Hartung and Deputy Director, Fenna Sillé! "Integration of metabolomics with computational, in vitro, and personalized medicine innovations will shape future applications in predictive toxicology." Use the link below to read on and learn more about how and why the integration of #metabolomics holds so much promise for the future of #toxicology! 🔬 🌟

Only one more day... Will we meet at the 9th Annual Pharm-Tox Summit in Munich from 13 – 15 March? Bioanalysis plays a critical role in early phase drug development. Here, BioAgilytix offers comprehensive preclinical support through our pharmacokinetics (PK) and drug metabolism, immunogenicity, biomarker, and CMC bioanalytical services. Reach out to me here on LinkedIn to schedule a meeting. I would love the opportunity to discuss your next toxicology project. #pharmtox #pharmacology #drugdiscovery #drugdevelopment #toxicology #MunichConference  #InnovationInScience

In the latest #CertaraTalks episode, Krista K. Greenwood, PhD, DABT, Director of Toxicology at Certara, shares key insights from the American College of Toxicology 2023 Annual Meeting. Explore highlights like Project Optimus, the FDA's groundbreaking dose optimization initiative for oncology products, and updates on the latest safety pharmacology best practices. For more on our early drug development expertise, visit our website: https://ow.ly/tM2j50QhX1y. Share your #ACTOX2023 highlights in the comments! 🌟 #Toxicology #DrugSafety

We invite you to publish your article in the International Research Journal of Pharmacy and Pharmacology, advancing global pharmaceutical science research. #RafahOnFire #WWERaw #Rhea #Pharmacodynamics #Pharmacokinetics #drugtwt #Toxicology #chemotherapy #Biopharmaceutics

Today I am in Tübingen representing #alveolix and the 3R Länd Conference is delivering a tremendous amount of innovation in MPS and NAMs. It is great to see how these advancements enable translational research for pharma companies participating in the event, while reflecting better drug development prediction in toxicology, efficacy and organ function upon drug treatment. #organonachip #drugdevelopment #toxicology

Patrys Limited (ASX:PAB) has confirmed that Good Manufacturing Practice (GMP) production of its drug PAT-DX1 is scheduled to begin in the first quarter of the 2024 calendar year. This development is a result of Patrys' collaboration with a Contract Manufacturing and Development Organisation (CDMO) that has secured a manufacturing slot for PAT-DX1. Patrys has also successfully completed GLP toxicology studies in both rats and non-human primates. The outcomes of these studies bolster the company’s confidence in the asset, with no significant safety or tolerability issues identified that might affect the upcoming Phase 1 clinical trial of PAT-DX1. More at #Proactive #ProactiveInvestors #ASX #PAB http://ow.ly/wmhz1055u3L

Watch as Dr. Makori shares the two primary points to keep in mind when preparing for a new preclinical study. https://lnkd.in/esG2nZia #DrugSafety #Pharmaceuticals #Toxicology