Certara’s Post

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

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

FDA Launches CDER Center for Clinical Trial Innovation to Revolutionize Drug Development Processes The FDA's Center for Drug Evaluation and Research (CDER) has established the CDER Center for Clinical Trial Innovation (C3TI), led by Dr. Patrizia Cavazzoni, to advance clinical trial innovation and address unmet medical needs. The goal is to streamline drug development processes, accelerate therapies, and tackle challenges in clinical research. C3TI will foster collaboration and communication, promote transparency and excellence in regulatory decision-making, and drive progress in drug development. The center will explore innovative approaches to clinical trial design, data collection, and analysis, with the aim of improving patient care and public health. C3TI will share insights and resources, oversee a demonstration program, and support the adoption of innovative modalities. The overall objectives are to keep stakeholders informed, enhance trial efficiency, promote diversity in participation, and expedite the development of safe and effective drugs. For more details please click the link! https://lnkd.in/d56zVxAE #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

REGISTER NOW 📆 C-Path's Predictive Safety Testing Consortium is delighted to announce its second public workshop on evidentiary considerations for regulatory assessment and qualification of complex in vitro models - CIVMs. Health authorities, academia professionals, model developers, and representatives from the pharmaceutical industry are encouraged to participate in this workshop. It offers a valuable platform for attendees to engage in discussions and deliberations regarding the evidentiary considerations essential for regulatory assessment and qualification of CIVMs. Through collaborative efforts, attendees will strive to reach a consensus on the standards and features necessary to enhance the performance of CIVMs as a reliable tool for drug development and regulatory assessment. The meeting agenda features sessions led by key opinion leaders, who will address general considerations for qualification. Additionally, interactive breakout sessions will concentrate on various organ systems and disease models. During these breakouts, participants will actively engage in discussions and deliberations to explore the evidentiary considerations crucial for regulatory assessment and qualification of complex in vitro models. Join us September 26 - 27, 2024 in Bethesda, Maryland. Register now: https://lnkd.in/gKXn8R4e. #CPath #PSTC #CIVM #workshop #drugdevelopment #datasharing #regulatoryscience #collaboration #globalhealth

𝐇𝐞𝐫𝐞 𝐢𝐬 𝐚 𝐬𝐢𝐦𝐩𝐥𝐢𝐟𝐢𝐞𝐝 𝐢𝐧𝐟𝐨𝐠𝐫𝐚𝐩𝐡 𝐟𝐨𝐫 𝐭𝐡𝐞 𝐬𝐭𝐚𝐠𝐞𝐬 𝐨𝐟 𝐝𝐫𝐮𝐠 𝐝𝐢𝐬𝐜𝐨𝐯𝐞𝐫𝐲 𝐟𝐫𝐨𝐦 𝐏𝐡𝐚𝐬𝐞 𝟎 𝐭𝐨 𝐩𝐡𝐚𝐬𝐞 𝟒.... 𝑷𝒓𝒆𝒄𝒍𝒊𝒏𝒊𝒄𝒂𝒍 𝒑𝒉𝒂𝒔𝒆: Is known to confirm the drugs efficacy and the hypothesis on a lab basis. 𝑷𝒉𝒂𝒔𝒆 𝟏 Is mainly known as the stage in which Evaluation of drug safety, pharmacokinetics studies and dose escalation are done on healthy participants. 𝑷𝒉𝒂𝒔𝒆 𝟐 Is mainly known as the stage in which Safety, tolerability and dosing is confirmed via participants with the disease. 𝑷𝒉𝒂𝒔𝒆 𝟑 Safety and efficacy are confirmed through evaluating the benefit risk and SE. 𝑷𝒉𝒂𝒔𝒆 𝟒 post marketing studies after drug's approval. #clinical_research #content_creation #pharmacy #Drug_discovery

📢 FDA Announces Final Guidance on M12 Drug Interaction Studies The FDA has released the final guidance for "M12 Drug Interaction Studies" and a supplemental Q&A document. Prepared by the ICH, this guidance offers recommendations on evaluating enzyme and transporter-mediated pharmacokinetic drug-drug interactions for investigational drugs. The aim is to harmonize regional guidelines for designing, conducting, and interpreting in vitro and clinical evaluations of drug interactions. This guidance replaces the draft issued on August 29, 2022. Know more - https://lnkd.in/eq4RMH97 #DrugDevelopment #Pharmacokinetics #FDA #ICH #DrugInteractions #clinicalstudy #pharmacovigilance

𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 𝗼𝗻 𝗙𝗗𝗔'𝘀 𝗠𝗼𝗱𝗲𝗹-𝗜𝗻𝗳𝗼𝗿𝗺𝗲𝗱 𝗗𝗿𝘂𝗴 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗣𝗮𝗶𝗿𝗲𝗱 𝗠𝗲𝗲𝘁𝗶𝗻𝗴 𝗣𝗿𝗼𝗴𝗿𝗮𝗺 Following a very successful and popular pilot, the FDA has formally instituted a 𝗠𝗼𝗱𝗲𝗹-𝗜𝗻𝗳𝗼𝗿𝗺𝗲𝗱 𝗗𝗿𝘂𝗴 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 (𝗠𝗜𝗗𝗗) Paired Meeting Program, designed to integrate advanced #modeling techniques in drug development and #regulatory processes.   By utilizing #quantitative methods that analyze #preclinical and #clinical data, the program aims to improve #clinicaltrial efficiency, enhance the probability of regulatory success, and optimize #drugdosing without dedicated trials. This program is a key part of the FDA's strategy to modernize #drugdevelopment and it represents a shift towards more data-driven, analytical approaches in evaluating new #medicalproducts.   ➡ As a company at the forefront of 𝗠𝗼𝗱𝗲𝗹-𝗜𝗻𝗳𝗼𝗿𝗺𝗲𝗱 𝗗𝗿𝘂𝗴 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 (𝗠𝗜𝗗𝗗) revolution, 𝗜𝗻𝗦𝗶𝗹𝗶𝗰𝗼𝗧𝗿𝗶𝗮𝗹𝘀 applauds the FDA's leadership in formalizing this vital program. If you would like to learn more about how #insilico technologies can help accelerate your drug development program, please contact us at info@insilicotrials.com. ℹ https://lnkd.in/ebY5Wphb

➡ The US Food and Drug Administration (FDA) Data Standards Catalog v10.3 has been published, and it contains information on the data standards that are currently required and planned for future use. ➡ The catalog includes quick links to key guidance documents to assist with the submission of study data to various US FDA centers. ➡ It also contains technical specifications for submitting various types of data, such as clinical trial datasets, bioanalytical methods, and patient-reported outcome data in cancer clinical trials. 👉 Download: US FDA Data Standards Catalog v10.3 https://lnkd.in/dBWunW_q FDA RegOrbit #datastandards #submissions #regulatoryaffairs #submissions #clinical #quality #pharmaceutical #ectd

Revised CDSCO Guidance for Industry to align with New Drugs and Clinical Trials Rules, 2019 and SUGAM application Process. Guidance for Industry : *Submission of Clinical Trial Application for Evaluating Safety and Efficacy *Requirements for Permission of New Drugs Approval *Preparation of the Quality Information for Drug Submission for New Drug Approval: Biotechnological/Biological Products

USFDA diverse research programs address a wide variety of critical areas that affect drug safety and manufacturing quality. we should follow the rules to compliance the latest requirements. In usfda regulatory science programs, areas include: * Applied regulatory science * Clinical pharmacology * Clinical trial methodology * Drug Development Tool Qualification Programs * Drug safety monitoring * Generic drugs and bioequivalence * Manufacturing innovation * Modernizing drug review * Prescription drug advertising and risk communication * Product quality assessment * Radioactive Drug Research Committee Program #usfda #regulatoryaffairs #regulatorycompliance #regulatoryintelligence