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Xyzagen

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Pittsboro, North Carolina, US

About Xyzagen

Xyzagen is a boutique consulting and contract research services firm. Our goal is to provide experienced scientific advice and affordable, quick response, contract nonclinical pharmacokinetics and pharmacology research to our clients. We understand resource constraints on companies in the early discovery... Show more »

Xyzagen is a boutique consulting and contract research services firm. Our goal is to provide experienced scientific advice and affordable, quick response, contract nonclinical pharmacokinetics and pharmacology research to our clients. We understand resource constraints on companies in the early discovery programs and can offer up unique solutions to meet your needs.

Xyzagen, in addition to its R&D consulting services in clinical pharmacology and nonclinical development, is focused on providing full service early pharmacokinetic studies within our rodent vivarium and LC/MS/MS bioanalysis capabilities and with our strategic vendors can also support large animal PK studies. We can couple rodent pharmacokinetics with pharmacology endpoints as well so clients can analyze their molecule's exposure-response relationship.

When you're ready to file your IND or NDA, we can also provide medical writing support in the nonclinical pharmacology and pharmacokinetics sections as well as the clinical biopharmaceutics and clinical pharmacology sections of your regulatory document.

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Diversity Certificates

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Our Services (26)


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Clinical Trial Design and Consulting

Price on request

Clinical pharmacology and pharmacokinetics phase 1 trial design and CRO competitive bid pricing are available from Xyzagen. Our clinical pharmacologists have experience in phase 1 intrinsic and extrinsic clinical pharmacokinetics and biopharmaceutics trial design and analysis. We can design your phase 1 study and then submit for... Show more »

Clinical pharmacology and pharmacokinetics phase 1 trial design and CRO competitive bid pricing are available from Xyzagen. Our clinical pharmacologists have experience in phase 1 intrinsic and extrinsic clinical pharmacokinetics and biopharmaceutics trial design and analysis. We can design your phase 1 study and then submit for RFP to turnkey Phase 1 clinical units that offer everything from regulatory submission through the ​final report or we can submit bids to phase 1 units that only support the clinical conduct if your organization has its own internal resources for data management and clinical trial oversight.

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Clinical Trial Monitoring

Price on request

Xyzagen's consultants have unique focused phase 1 clinical trial monitoring that allows for a more focused monitoring experience of a phase 1 unit than other organizations that are focused on trial monitoring in Phase 2 and Phase 3 trial settings. Talk to us about how we can support your Phase 1 trial from trial design, monitoring through PK analysis and reporting.

Xyzagen's consultants have unique focused phase 1 clinical trial monitoring that allows for a more focused monitoring experience of a phase 1 unit than other organizations that are focused on trial monitoring in Phase 2 and Phase 3 trial settings. Talk to us about how we can support your Phase 1 trial from trial design, monitoring through PK analysis and reporting.

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In vivo PK/PD Studies

Price on request

Xyzagen's scientists have extensive experience in conducting early discovery pharmacokinetic studies in rodents, rabbits, dogs and monkeys. We provide turn key solutions for early phase biotechs trying to understand the PK of their molecules, from formulation support, dosing, sample collection, drug and metabolite bioanalysis,... Show more »

Xyzagen's scientists have extensive experience in conducting early discovery pharmacokinetic studies in rodents, rabbits, dogs and monkeys. We provide turn key solutions for early phase biotechs trying to understand the PK of their molecules, from formulation support, dosing, sample collection, drug and metabolite bioanalysis, pharmacokinetic interpretation and report writing. Our PK/PD modeling and pharmacology capabilities will allow the sponsor to better understand the exposure response relationship of their molecules early in their discovery/development phase. We can also analyse select tissues to better inform about target tissue engagement of your molecule.

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Agilent 1100 AB Sciex API4000 LC/MS/MS tissue homogenizers CTC Pal autosampler Rabbit Mouse Rat Dog Cynomolgus monkey Phoenix® CNS/Neurology Pain Infectious Disease Ophthalmology Neuropathy Epilepsy Show 17 more tags Show less

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PK/PD Study Design

Pharmacokinetics/Pharmacodynamics Study Design
Price on request

PK/PD assessments should start with your nonclinical species to support a better understanding of your initial and maximal doses in Phase 1 healthy volunteer studies. Our pharmacokineticists can merge your nonclinical datasets and analyze for exposure response relationships that will support your model based drug design.

PK/PD assessments should start with your nonclinical species to support a better understanding of your initial and maximal doses in Phase 1 healthy volunteer studies. Our pharmacokineticists can merge your nonclinical datasets and analyze for exposure response relationships that will support your model based drug design.

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Integrated Drug Discovery

Price on request
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Bioanalysis

Price on request

Small Molecule Drug Bioanalysis services in support of early discovery nonGLP PK support. Our scientists can develop fit for purposes nonGLP bioanalytical methods in order to support your early small molecule pharmacokinetic assessments or in vivo compound screening. We can continuously​ refine the method cost effectively as... Show more »

Small Molecule Drug Bioanalysis services in support of early discovery nonGLP PK support. Our scientists can develop fit for purposes nonGLP bioanalytical methods in order to support your early small molecule pharmacokinetic assessments or in vivo compound screening. We can continuously​ refine the method cost effectively as your program advances and then transfer it to a GLP bioanalytical facility in support of your IND enabling toxicology studies and clinical program.

In addition, our consultants have numerous contacts at 3rd party vendors for large molecule bioanalysis and can provide oversight of your programs.

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AB Sciex API4000

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Drug Discovery Consulting

Price on request
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Epilepsy & Seizure Animal Models

Price on request

Our scientists have developed and validated the Maximal Electroshock assay and a number of chemical convulsant assays (bicuculline, strychnine, and pentylenetetrazole (PTZ)). We're currently validating a number of kindling models and febrile seizure models. Ask us about our experience in nonclinical clinical epilepsy drug development.

Our scientists have developed and validated the Maximal Electroshock assay and a number of chemical convulsant assays (bicuculline, strychnine, and pentylenetetrazole (PTZ)). We're currently validating a number of kindling models and febrile seizure models. Ask us about our experience in nonclinical clinical epilepsy drug development.

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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
Price on request

Xyzagen offers unique rodent pharmacokinetic studies, such as bile duct or portal vein cannulated rats, to investigate reasons of assumed poor drug absorption. We can offer unique routes of administration and tissue analysis in the assessment of drug disposition. No study is too complicated to discuss and undertake.

Xyzagen offers unique rodent pharmacokinetic studies, such as bile duct or portal vein cannulated rats, to investigate reasons of assumed poor drug absorption. We can offer unique routes of administration and tissue analysis in the assessment of drug disposition. No study is too complicated to discuss and undertake.

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In vivo ADME/DMPK Studies

Price on request

Xyzagen offers unique rodent pharmacokinetic studies, such as bile duct or portal vein cannulated rats, to investigate reasons of assumed poor drug absorption. We can offer unique routes of administration and tissue analysis in the assessment of drug disposition. No study is too complicated to discuss and undertake.

Xyzagen offers unique rodent pharmacokinetic studies, such as bile duct or portal vein cannulated rats, to investigate reasons of assumed poor drug absorption. We can offer unique routes of administration and tissue analysis in the assessment of drug disposition. No study is too complicated to discuss and undertake.

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Clinical Pharmacology

Price on request

Our consultants can help design your clinical pharmacology & pharmacokinetics study in support of your IND program. We have experience in designing DDI, intrinsic and extrinsic studies. Our bioanalysts can manage the outsourced bioanalytical methods and our pharmacokineticists can analyze the bioanalytical data and provide an assessment of the pharmacokinetic parameters.

Our consultants can help design your clinical pharmacology & pharmacokinetics study in support of your IND program. We have experience in designing DDI, intrinsic and extrinsic studies. Our bioanalysts can manage the outsourced bioanalytical methods and our pharmacokineticists can analyze the bioanalytical data and provide an assessment of the pharmacokinetic parameters.

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Toxicokinetic (TK) Modeling

Price on request

Xyzagen's pharmacokineticists, SOPs and Quality Assurance group are able to provide clients with GLP regulated toxicokinetic analysis. Having a consulting group that understands the pharmacokinetics of your molecule and can provide the regulated TK analysis and Clinical Pharmacokinetics analysis is important as your product... Show more »

Xyzagen's pharmacokineticists, SOPs and Quality Assurance group are able to provide clients with GLP regulated toxicokinetic analysis. Having a consulting group that understands the pharmacokinetics of your molecule and can provide the regulated TK analysis and Clinical Pharmacokinetics analysis is important as your product progresses in development from a preIND candidate to a Phase 1 asset. Ask us about our GLP TK analysis and reporting capabilities and competitive pricing.

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Pain/Neuropathy Animal Models

Price on request

Experience in classic models of acute, chronic and neuropathic pain assessment; such as hot plate, formalin, and carrageenan induced inflammatory pain, acetic acid writhing and neuropathic models such as Chung and Bennett models.

Experience in classic models of acute, chronic and neuropathic pain assessment; such as hot plate, formalin, and carrageenan induced inflammatory pain, acetic acid writhing and neuropathic models such as Chung and Bennett models.

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rotarod bioseb hotplate IITC thermal and mechanical hyperalgesia allodynia IITC

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Gap Analysis

Price on request

Our consultants can review your in-licensing opportunity and assess what nonclinical pharmacology and pharmacokinetic studies are needed for IND and map out a development strategy with pricing so that your finance team can add the timing and cost to their valuation assessment. Talk to us about how we can also support your clinical pharmacology gap analysis.

Our consultants can review your in-licensing opportunity and assess what nonclinical pharmacology and pharmacokinetic studies are needed for IND and map out a development strategy with pricing so that your finance team can add the timing and cost to their valuation assessment. Talk to us about how we can also support your clinical pharmacology gap analysis.

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Pharmaceutical Due Diligence

Price on request

Our consultants can review your in-licensing opportunity and assess what nonclinical pharmacology and pharmacokinetic studies are needed for IND and map out a development strategy with pricing so that your finance team can add the timing and cost to their valuation assessment. Talk to us about how we can also support your clinical pharmacology gap analysis.

Our consultants can review your in-licensing opportunity and assess what nonclinical pharmacology and pharmacokinetic studies are needed for IND and map out a development strategy with pricing so that your finance team can add the timing and cost to their valuation assessment. Talk to us about how we can also support your clinical pharmacology gap analysis.

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Regulatory Document Preparation and Submission

Price on request

Talk to our consultants about their experience in 505(b)(1) and 505(b)(2) Type A, B and C meeting requests, IND annual reports and Advisory Committee meeting preparation and participation. Our consultants are experienced in successfully interacting with multiple CDER divisions. We have written multiple CTD modules for multiple... Show more »

Talk to our consultants about their experience in 505(b)(1) and 505(b)(2) Type A, B and C meeting requests, IND annual reports and Advisory Committee meeting preparation and participation. Our consultants are experienced in successfully interacting with multiple CDER divisions. We have written multiple CTD modules for multiple clients and have never experienced a clinical hold or a refusal to file.

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Rodent Models

Price on request

Xyzagen is a boutique contract research lab with rodent models in pain, neurology, behavioral assessments, and epilepsy/seizure models. We can also work with Sponsor's to custom design bespoke models or transfer academic models to our CRO in order to cost-effectively screen your discovery molecule platform to identify and advance... Show more »

Xyzagen is a boutique contract research lab with rodent models in pain, neurology, behavioral assessments, and epilepsy/seizure models. We can also work with Sponsor's to custom design bespoke models or transfer academic models to our CRO in order to cost-effectively screen your discovery molecule platform to identify and advance a preIND candidate forward to IND candidate selection. It's consultants also have an extensive network of additional CROs that can provide ophthalmic disease models and other neurology models.

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Neurodegeneration Animal Models

Price on request
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Alzheimer's Disease Animal Models

Price on request
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Parkinsons Disease Animal Models

Price on request
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CNS/Neurology Animal Models

Price on request

CNS/Neurology Animal Models Services

CNS/Neurology Animal Models Services

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Drug Discovery & Development

Price on request

Xyzagen offers an opportunity for companies to cost effectively conduct in vivo PK and drug metabolism screens in mice and rats in order to optimize the PK of their chemical series. Our scientists have been involved in numerous​ bench to bedside discovery and development programs and understand how to efficiently pare down a PK... Show more »

Xyzagen offers an opportunity for companies to cost effectively conduct in vivo PK and drug metabolism screens in mice and rats in order to optimize the PK of their chemical series. Our scientists have been involved in numerous​ bench to bedside discovery and development programs and understand how to efficiently pare down a PK assessment in order to extract the most information to inform your candidate selection.

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Clinical Trials, Consulting, and Management

Price on request

Clinical pharmacology and pharmacokinetics phase 1 trial design and CRO competitive bid pricing are available from Xyzagen. Our clinical pharmacologists have experience in phase 1 intrinsic and extrinsic clinical pharmacokinetics and biopharmaceutics trial design and analysis. We can design your phase 1 study and then submit for... Show more »

Clinical pharmacology and pharmacokinetics phase 1 trial design and CRO competitive bid pricing are available from Xyzagen. Our clinical pharmacologists have experience in phase 1 intrinsic and extrinsic clinical pharmacokinetics and biopharmaceutics trial design and analysis. We can design your phase 1 study and then submit for RFP to turnkey Phase 1 clinical units that offer everything from regulatory submission through the ​final report or we can submit bids to phase 1 units that only support the clinical conduct if your organization has its own internal resources for data management and clinical trial oversight.

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Regulatory Review, Certification and Product Registration

Price on request

Regulatory Review, Certification and Product Registration Services

Regulatory Review, Certification and Product Registration Services

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Drug Discovery

Price on request

Drug Discovery Services

Drug Discovery Services

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Preclinical Study Design

Price on request

Early stage biotech companies should provide sponsor oversight to their critical early stage nonclinical studies. However, this is not always possible when the company is virtual with only a couple of employees working out of a small office or from the VC firm that is funding the discovery round investment. But, not all CROs... Show more »

Early stage biotech companies should provide sponsor oversight to their critical early stage nonclinical studies. However, this is not always possible when the company is virtual with only a couple of employees working out of a small office or from the VC firm that is funding the discovery round investment. But, not all CROs understand the research like you do so some key aspects of a study may be overlooked; "the soft data". Talk to us about how we can deploy our nonclinical study monitors to your selected vendor or academic lab to oversee key aspects of your critical nonclinical 'Proof of Concept' studies.

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