Certara’s Post

Streamlining the journey from drug discovery to market is more than a goal—it's a necessity. Our latest white paper explores how 𝗦𝗶𝗺𝗰𝘆𝗽 𝗣𝗕𝗣𝗞 (𝗽𝗵𝘆𝘀𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹𝗹𝘆-𝗯𝗮𝘀𝗲𝗱 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝗸𝗶𝗻𝗲𝘁𝗶𝗰) 𝗺𝗼𝗱𝗲𝗹𝗶𝗻𝗴 𝗮𝗻𝗱 𝘀𝗶𝗺𝘂𝗹𝗮𝘁𝗶𝗼𝗻 can enhance drug development efficiency and mitigate potential risks. Click here to learn more: https://ow.ly/htCm50RcnG3 #DrugDevelopment #RegulatorySuccess #DrugApproval #FDA #Pharmacokinetics #PBPK #DDIAssessment #FDAApproval #RegulatoryGuidance #PBPKModeling #DrugLabeling #PharmaceuticalInnovation #DrugInteractions #PharmaIndustry #ClinicalPharmacology #FasterDrugApproval

Explore how advancements in pharmacogenomic testing are revolutionizing drug development, enhancing precision medicine, and improving patient outcomes. https://lnkd.in/gPE-vZxS #apgxa #pgx #pharmacogenomics #drugdevelopment

Correctly identifying the recommended phase 2 dose (RP2D) is a make-or-break activity in clinical drug development. In a recent white paper, we talked about how to use pharmacokinetic/ pharmacodynamic (PK/PD) modeling to select the RP2D by predicting therapeutically active concentrations. In another white paper, we delved into how PK or dose/ toxicity modeling can be used to get an accurate handle on the toxicity constraints crucial for RP2D selection.   This white paper integrates these concepts into a comprehensive strategy aimed at identifying the ideal RP2D. The goal is to minimize the risk of failure in Phase II trials, whether due to poor tolerability or insufficient therapeutic activity.   By combining insights from PK/PD and dose/toxicity modeling, we can better predict the optimal dose that balances efficacy and safety. This approach maximizes the likelihood of clinical success, ensuring that the chosen dose is both effective and well-tolerated by patients.   If you’d like more information on this critical topic, we invite you to join our upcoming webinar on June 6th, where we will cover each aspect in detail, providing a deeper understanding of the strategies involved in RP2D selection. #RP2D #DoseSelection #PKPD #ClinicalDevelopment

Explore how advancements in pharmacogenomic testing are revolutionizing drug development, enhancing precision medicine, and improving patient outcomes. https://lnkd.in/gM8nwgER #apgxa #pgx #pharmacogenomics #drugdevelopment

Reduce unnecessary clinical drug-drug interaction (DDI) trials and gain unparalleled insights into complex DDIs with the Simcyp Simulator. This industry-leading platform can streamline your DDI assessments and accelerate drug development. Read more here in our latest white paper: https://ow.ly/htCm50RcnG3 #DrugDevelopment #RegulatorySuccess #DrugApproval #FDA #Pharmacokinetics #PBPK #DDIAssessment #FDAApproval #RegulatoryGuidance #PBPKModeling #DrugLabeling #PharmaceuticalInnovation #DrugInteractions #PharmaIndustry #ClinicalPharmacology #FasterDrugApproval

🧠 Trivia Time! 🩺 In the context of clinical trials, what is the primary purpose of a Phase II study? A) To assess the long-term safety of a drug in a large patient population. B) To evaluate the drug's efficacy and further study its safety in a larger group of people. C) To determine the pharmacokinetics and pharmacodynamics of a drug in healthy volunteers. D) To monitor adverse reactions in post-marketing surveillance. #ClinicalTrials #MedicalResearch #Pharmaceuticals #HealthScience Sciqst, Precise References in Medicine. www.sciqst.com

Grateful to have received a certificate for attending a one-day National conference on AI for Pharmacists and delivered oral presentation on 'Transethosomes: A Novel Approach for Enhanced Transdermal Drug Delivery.' It was a rewarding experience to share insights on innovative drug delivery systems in the evolving field of pharmacy. #TransdermalDrugDelivery #PharmaceuticalInnovation #Transethosomes #OralPresentation #PharmacySeminar #DrugDeliveryTechnology #PharmacistEducation

Biosimilars have been witnessing a significant shift, capturing the industry's attention due to their potential cost-effectiveness. Injectable drug delivery, in particular, is attracting significant focus driven by the rising prevalence of chronic diseases and the demand for biologics and biosimilars.   Veeda Group has successfully conducted injectable biosimilar studies for molecules like ADL-018 (XOLAIR), demonstrating our capability to navigate the complex requirements of biosimilar development. Our experience includes: - Rigorous Analytical Testing: Implementing advanced ELISA and LC-MS/MS techniques to ensure biosimilarity in terms of structure, function, and clinical performance. - Comprehensive PK/PD Profiling: Providing detailed insights into the pharmacokinetics and pharmacodynamics of biosimilar candidates, ensuring they meet regulatory standards.   Check out our detailed Injectable Flyer: https://bit.ly/3y0eUAp   To know more about our injectable biosimilar experience write to us at info@veedacr.com or visit us www.veedacr.com Partners in creating a healthier tomorrow. #VeedaGroup #ClinicalResearch #VeedaCR #Veeda #InjectableBiosimilars #BiosimilarStudies #BiosimilarDevelopment

The FDA's nod towards using PBPK (physiologically-based pharmacokinetic) technology for DDI assessment means that the path to safer and more efficient drug development is clearer than ever. Our white paper discusses how Simcyp PBPK technology is shaping the future of pharmacokinetic assessment, including its critical role in bridging from oral to long-acting formulations. Read more here: https://ow.ly/htCm50RcnG3 #DrugDevelopment #RegulatorySuccess #DrugApproval #FDA #Pharmacokinetics #PBPK #DDIAssessment #FDAApproval #RegulatoryGuidance #PBPKModeling #DrugLabeling #PharmaceuticalInnovation #DrugInteractions #PharmaIndustry #ClinicalPharmacology #FasterDrugApproval

𝐅𝐢𝐯𝐞 𝐌𝐨𝐬𝐭 𝐂𝐨𝐦𝐦𝐨𝐧 𝐑𝐞𝐚𝐬𝐨𝐧𝐬 𝐏𝐡𝐚𝐬𝐞 1 𝐃𝐫𝐮𝐠 𝐂𝐚𝐧𝐝𝐢𝐝𝐚𝐭𝐞𝐬 𝐅𝐚𝐢𝐥 🤔 Navigating the path from the laboratory bench to the pharmacy shelf poses a challenge in drug development. Although the likelihood of success increases in later phases, Phase 1 trials represent a crucial juncture where numerous drug candidates may encounter failure. #biotech #drugdiscovery #drugdevelopment #therapeutics