Certara’s Post

𝗣𝗵𝘆𝘀𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹𝗹𝘆-𝗯𝗮𝘀𝗲𝗱 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝗸𝗶𝗻𝗲𝘁𝗶𝗰 (𝗣𝗕𝗣𝗞) 𝗺𝗼𝗱𝗲𝗹𝗶𝗻𝗴 is an innovative approach for assessing complex drug-drug interactions (DDIs), informing drug labeling, and potentially even eliminating some clinical trials. Our latest white paper explores PBPK's strategic use, showcasing its power to predict DDIs. Discover how PBPK is transforming drug development and accelerating the delivery of safer, more effective treatments to patients. Read more here: https://ow.ly/htCm50RcnG3 #DrugDevelopment #RegulatorySuccess #DrugApproval #FDA #Pharmacokinetics #PBPK #DDIAssessment #FDAApproval #RegulatoryGuidance #PBPKModeling #DrugLabeling #PharmaceuticalInnovation #DrugInteractions #PharmaIndustry #ClinicalPharmacology #FasterDrugApproval

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

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

💊𝗧𝗮𝗸𝗲 𝗮𝗱𝘃𝗮𝗻𝘁𝗮𝗴𝗲 𝗼𝗳 𝗗𝗗𝗜 𝗦𝗶𝗺𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀 𝘁𝗼 𝗼𝗽𝘁𝗶𝗺𝗶𝘇𝗲 𝘆𝗼𝘂𝗿 𝗱𝗿𝘂𝗴 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁! At PhinC Development, we specialize in providing comprehensive solutions for informing Drug-Drug Interactions risks in clinical studies.    By leveraging our expertise in pharmacokinetic modeling and simulation, we allow to biotechs to go through the step of #DDI with confidence, ultimately advancing their clinical development in a safer way for patients.   Let's enhance clinical develoment! ➡ https://lnkd.in/eeFrmXkC #Pharmacokinetics #DrugInteractions #ClinicalStudies #SimulationModeling

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

🌟 Drug Repositioning🌟 🌐 It's also known as "drug repurposing" or "drug reprofiling". Simply, exploring new uses for existing medications so, it is giving new indications for existing FDA-approved medications that were not previously referenced and not currently prescribed or investigated. Repurposed drugs benefit from existing pharmacological and safety data, expediting clinical trials and FDA review. so .. we can potentially discover innovative treatments faster and more cost-effectively than developing new drugs from scratch. 🚀💊 this approach uncovers new mechanisms of action for existing compounds or finds new uses for established targets in different disease areas.🧠💡 #DrugRepositioning #DrugRepurposing #Medical #Healthcare #indication #Pharmaceutical #Research Good Read: Jourdan, J. P., Bureau, R., Rochais, C., & Dallemagne, P. (2020). Drug repositioning: a brief overview. Journal of Pharmacy and Pharmacology, 72(9), 1145-1151.

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

Christmas Countdown: Unveil the festive spirit with our exclusive discounts! Hurry, while the magic lasts! Closing registrations soon for the PK/PD in Drug Discovery and Development MasterClass - EU Edition: https://lnkd.in/gZVayx6U Master the crucial aspects of the first in human study design, conduction, and interpretation. Dive deep into the realm of Pharmacokinetics (PK) and Pharmacodynamics (PD) in drug discovery and development with our intensive MasterClass tailored for the EU landscape. This session promises to provide participants with an in-depth understanding of the science and intricacies behind PK/PD studies in the pharmaceutical industry. 🗓️ Dates: 12th - 15th December, 2023 🌍 Location: Virtual 🎓 Speaker: Dr. Stefano Persiani Don't miss out on this unique chance to bolster your knowledge in the field of PK/PD, pivotal in drug efficacy and safety evaluation. As slots are limited, we urge you to act promptly. Enroll now and embark on a journey to unravel the complexities of PK/PD in drug discovery and development! #masterclass #glceurope #globalleadingconferences #pharmacokinetics #pharmacodynamics #drugdevelopment #professionaldevelopment

Inotiv offers expert PK, TK, and PD services with rapid turnaround for all drug development stages. Leverage the experience of industry-trained scientists in all stages of drug discovery, from target ID to new drug application (NDA). Download our infographic to learn more. https://hubs.ly/Q02k4z7v0 #Inotiv #DMPK #Pharmacokinetics #Toxicokinetics #Pharmacodynamics

🔥Hot off the press 🔥 In an era marked by unprecedented therapeutic breakthroughs, analytical lab service providers are diversifying their testing strategies to enhance efficiency and speed. Experts highlight the need for new analytical methods as fast-emerging therapeutic modalities, like cellular and molecular medicines, push the boundaries of current pharmacokinetic and immunogenicity assessments. Read as Contract Pharma dives deep into the versatility of contract labs in their recent feature, including how Alcami Corporation is leading the charge in the CDMO space, offering comprehensive analytical development services for various therapeutic modalities. Our flexibility and agility are demonstrated through method establishment, validation, QC testing, and more. With a recent strategic partnership with Tanvex CDMO, Alcami continues to expand its capabilities, providing end-to-end analytical support from bulk drug production to finished drug product. Read more ➡️https://gag.gl/zyguUw #PharmaStorage #MedicalDeviceStorage #LifeSciences #cGMP #Alcami #Biopharma #ControlledStorage #ProductIntegrity #PatientSafety #Efficacy #BusinessSolutions #AmbientStorage #ShelfStable #APIStorage #Pharmaceuticals