Xyzagen, Inc.
BioTech/Drugs - Pittsboro, NC, US
Xyzagen, Inc. Employees
Xyzagen, Inc. Senior Management
Xyzagen, Inc. Details
Xyzagen is a focused contract research & IND/NDA consulting firm. Our focus is on early to mid-stage biotech start-ups. We can cost-effectively support your initial understanding of your molecule's pharmacokinetics through our First-in-Rodent PK solutions in the lab. We offer rapid turnaround bioanalysis of small molecules in either fluids or tissues and can couple our in vivo capabilities with our drug development experience and provide options in compound screening, cassette dosing, rodent DDI studies or whatever PK challenge you may have within your program. With our microsampling capabilities, we can combine PK and PD behavioral endpoints in pain and epilepsy so you can better understand your drug's exposure-response relationship. From a single First-in-Rodent PK study, we can model and simulate your drug's exposure to predict exposure in larger animals. This saves you time and money as your drug proceeds to IND enabling toxicology studies. After you've collected data in 2-3 species, we can then help guide you in your First-In-Human protocol design and dose rationale.Our consultants are experienced nonclinical and clinical pharmacologists. We have extensive experience in nonGLP nonclinical PK and GLP TK study design, analysis and reporting as well as Phase 1 and 2 clinical pharmacokinetic study design, analysis and reporting. Our consultants and medical writers have been involved in over 30 IND and NDA submissions. If you have questions regarding your program and if it is ready for submission to the FDA then talk to us about our approach to a gap analysis. Contact us at solutions@xyzagen.com or information@xyzagen.com for more information about how we can support your research to move your asset to the next value inflection point and funding round.
Xyzagen, Inc. Technologies
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