At Xyzagen, we specialize in toxicokinetics (TK) which is the study of how a drug’s absorption, distribution, metabolism, and excretion affect its toxicity. By analyzing TK data, we help Toxicologists, Clinical Operations and Regulatory understand the exposure risk and safety multiples that allow for dose escalation or risk associated with a proposed clinical dose. Our expertise in pharmacokinetics allows us to not only characterize the noncompartmental TK but also integrate multiple toxicology studies and model and simulate the toxicokinetic profile of a client's drug. Explore how our toxicokinetic services can enhance the safety and efficacy of your compounds by visiting us at xyzagen.com. #Xyzagen #Toxicokinetics #ADME #DrugDevelopment #Toxicology #SafetyAssessment #FirstInRodent #FirstInMouse #FirstInRat
Xyzagen, Inc.
生物技术研究
Pittsboro,North Carolina 406 位关注者
PK Consultancy: Clin Pharm, PopPK, PBPK, Regulatory Support. Research: Behavioral pharmacology, ADME, in vivo PK
关于我们
Xyzagen augments a client’s pharmacology and pharmacokinetics drug development team.? As a leading pharmacokinetics consultancy and contract research organization with wet lab and rodent vivarium facilities, Xyzagen is able to push model informed drug development into its First-in-Rat? and First-in-Mouse? discovery platforms as well as support late stage clinical noncompartmental PK, PopPK and Quantitative Medicine.?Our knowledge in pharmacology and pharmacokinetics allows the client to expand their core scientific team during the critical period of candidate selection up to the PreIND meeting and through clinical development and the preNDA meeting. Xyzagen’s a boutique organization which allows small clients to work directly and strategically with experts during their drug development programs.
- 网站
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https://www.xyzagen.com
Xyzagen, Inc.的外部链接
- 所属行业
- 生物技术研究
- 规模
- 11-50 人
- 总部
- Pittsboro,North Carolina
- 类型
- 私人持股
- 创立
- 2018
- 领域
- pharmacokinetics、pharmacology、GLP toxicokinetics、clinical pharmacology、PK modeling and simulation、IND, NDA submissions、compound repository、drug bioanalysis、vendor audits、nonclinical and clinical trial monitoring、ophthalmology、neurology、pain、epilepsy、antiinfectives、First-in-Rodent PK、Drug Drug Interaction Studies、Rodent Pharmacology Services和R&D Consulting
地点
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主要
480 Hillsboro St
Suite 140
US,North Carolina,Pittsboro,27312
Xyzagen, Inc.员工
动态
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FDA published two case studies and a case study user guide developed as part of the Accelerating Rare disease Cures (ARC) Program’s Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D) initiative. The ARC Program launched LEADER 3D to better understand and address the unique challenges in bringing rare disease products to market. These case studies highlight approaches successfully used by sponsors when designing and conducting rare disease drug development programs. The materials on the LEADER 3D website are reflective of the needs and priorities heard from our valuable partners in the rare disease drug development community. Learn more and read the case studies: https://lnkd.in/eEW-xreB
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When planning toxicokinetic (TK) studies, understanding the differences between GLP and non-GLP approaches is key to making the right decision for your research needs. The main difference between GLP and non-GLP TK studies is Quality Assurance (QA) oversight, not the scientific quality of the TK analysis itself. A non-GLP study offers a faster, cost-effective option when regulatory compliance is not required. At Xyzagen, our scientists can help determine the best approach for your study needs. Learn more by visiting our website: xyzagen.com #Xyzagen #Toxicokinetics #ADME #DrugDevelopment #Toxicology #SafetyAssessment #FirstInRodent #FirstInMouse #FirstInRat
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Counting down to #VentureConnect2025! ?? If you’re attending, let’s connect to explore how we can accelerate your drug pipeline with tailored strategies and innovative solutions. Book a meeting today to see how Xyzagen can support your R&D goals. https://buff.ly/6LKhulP #Pharma #LifeSciences #DrugDevelopment #Innovation #VentureConnect2025 #BiotechStartups #Xyzagen #FirstInRodent #FirstInMouse #FirstInRat
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Proud moment for Xyzagen! Some of our scientific staff have recently been coauthors on a publication that highlights CPL-01’s pharmacokinetic profiles in post-surgical pain management with more consistent and predictable drug release compared to liposomal bupivacaine. We’re excited to contribute to this critical research. Read the full study for all the details: https://buff.ly/o69xINa #Xyzagen #Pharmacokinetics #Innovation #PainManagement #FirstInRodent #FirstInMouse #FirstInRat
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Exciting news! The Xyzagen team is heading to #VentureConnect2025, the Southeast’s Premier Biotech Investment Conference! Xyzagen is proud to be a sponsor of Venture Connect 2025, happening March 25-27 in Raleigh, NC. This event connects innovative biotech startups, investors, and industry leaders to drive the future of life sciences. Stop by our booth and lets discuss how Xyzagen partners with early stage drug developers. We have partnered with 100+ life sciences innovators utilizing our offerings from candidate selection, nonclinical rodent vivarium for #FirstInRodnet studies, bioanalytical labs, PK/PD analysis and regulatory support all under one roof. We look forward to seeing you soon! #LifeSciences #DrugDevelopment #Innovation #BiotechStartups #Xyzagen #CED #FirstInMouse #FirstInMouse #FirstInRodent
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Partner with Xyzagen for your next pharmacokinetic and quantitative medicine study. Our expertise spans from PK study design to regulatory submissions, offering support in bioanalysis, toxicokinetics, and predictive modeling. By integrating quantitative measures with advanced PK/PD modeling, we provide data-driven insights and the biological impact of your therapy. Need help simulating drug exposure for Phase 1 or preparing for Phase 2 trials? Schedule a consultation today to explore the best path forward for your drug development plans. https://buff.ly/4cYU6HX #Xyzagen #QuantitativeMedicine #Pharmacokinetics #FirstInRat #FirstInMouse
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With over 25 clinical pharmacology and pharmacokinetics (PK) studies analyzed and reported, Xyzagen delivers expertise and precision to support your drug development programs. Our team ensures high-quality data interpretation to inform key decisions at every stage. Partner with us to advance your clinical research by scheduling a consultation at https://buff.ly/3BXef4L #Xyzagen #NonclinicalPK Pharmacokinetics #FirstInRat #FirstInMouse
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Xyzagen offers comprehensive, rodent PK analysis designed to inform and optimize your drug development strategy. By analyzing PK samples beyond plasma—such as urine, feces, and blood—we deliver a detailed understanding of drug absorption, distribution, and excretion. Our approach also includes behavioral observational data to assess general tolerability to your product. These studies provide critical insights into program viability and strategy refinement, helping drive informed decision-making while managing the costs of your research and development efficiently. Ready to take the next step toward drug development? Visit our website to connect with our experts and explore how Xyzagen can support your drug development needs! https://buff.ly/3BXef4L #Xyzagen #NonclinicalPK Pharmacokinetics #FirstInRat #FirstInMouse
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In today's age of easy misinformation it's important for the pharmaceutical research community to be comfortable talking about the importance of in vivo research and the translatability to humans. We're committed to the safe development of effective drugs.
CEO SYNAPTIGEN Group - Executive l Commercial Strategy I Business Development I Consulting I Clinical Research l FND & Rare Disease Patient Advocate l Coach l Team Builder | PKDPro? | #PatientPoweredBusiness
Why are animal studies still essential in drug development? In this clip from Beyond the Data Podcast, Christopher Crean, Founder & CEO of Xyzagen, Inc., breaks down the crucial role of animal models in nonclinical and preclinical research. He explains how these studies help ensure human safety and advance medical breakthroughs. Whenever possible, Xyzagen utilize testing methods that will reduce the "N" in nonclinical and preclinical studies. Chris shares why animal studies remain a fundamental step in the drug development process. His insights come from 30+ years of experience in many roles in Pharma, Consulting and CRO's. He also co-founded a drug development company and sold the drug to Pharma, adding not only insights in providing a service, but has the mindset when working with clients providing services like it were his own asset on every study his team conducts. Watch the full clip to understand: The scientific rationale behind animal studies How these studies protect human trial participants #Biotech #DrugDevelopment #3Rs #FirstInRat #FirstInMouse #Xyzagen #BeyondTheDataPodcast #AnimalModels #DrugResearch