XP Pharma Consulting is a service provider specializing in the design and implementation of clinical pharmacology-guided and model-informed drug development across the drug development spectrum and through registration.
Our Expert Services:
Noncompartmental PK Analysis (NCA)
• NCA analysis with validated software tools
• NCA analysis results (tables, listings, and figures)
• PK-dose proportionality assessment
• NCA results interpretation and authoring reports
Pharmacometrics Modeling & Simulation
• Population PK analysis
• PK exposure-response (E-R) analysis
• Concentration-QT analysis and modeling
• Dose selection and justification
• NONMEM data set preparation
• Identify intrinsic and extrinsic factors impacting PK exposure
• Dose simulations for different populations and formulations
• Author submission-ready reports
•
Clinical Pharmacology Strategy and Writing
• Clinical pharmacology plan
• Regulation document preparation (PK/PD)
• Responses to regulatory questions
• Gap analyses and mitigation strategy
• Author clinical study protocols and reports
• Dose rationale and justification
• PK/PD design in protocols
• DDI waiver justifications
• TQT waiver justification
• PIP and PSP for EU and US regulatory
Clinical Pharmacology Studies
• First-in-human (FIH)
• Single ascending dose (SAD)
• Multiple ascending doses (MAD)
• Bioequivalence /Relative bioavailability
• Food effects
• Drug-drug interactions (DDI)
• Thorough QT/QTc (TQT)
• Special populations
• Radio-labeled mass balance and ADME
NDA and BLA Filing
• Authoring CTD m.2.7.1, m.2.7.2 and contributes to other modules
• USPI and SmPC PK and PD sections
• Integrated PK and PK/PD analyses
• Integrated immunogenicity analyses
• Regulatory representation
• Ad hoc PK/PD analyses
Company Details
- Employees
- 1
- Founded
- -
- Address
- 11 Coventry Ln, Stoneham,ma 02180-1609,united States
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- https://xppharmaconsulting.com/
- Keywords
- Pharmacodynamics, Pharmacometrics, Clinical Drug Development, Clinical Trial Design, Pharmacokinetics, Regulatory Strategy, Population PK modeling, noncompartmental PK (NCA) analysis, all types of clinical pharmacology studies (TQT, DDI, ADME, SAD, MAD, Food effect, BE, etc), Population PK/PD modeling, NONMEM, IQnca, R packages for data science.
- HQ
- Stoneham, MA
Xp Pharma Consulting, Llc Questions
Xp Pharma Consulting, Llc's website is https://xppharmaconsulting.com/
Xp Pharma Consulting, Llc's LinkedIn profile is https://www.linkedin.com/company/xp-pharma-consulting-llc
Xp Pharma Consulting, Llc has
1 employees.
View email and phone details for 1
employees at Xp Pharma Consulting, Llc.
Xp Pharma Consulting, Llc's industry is
Pharmaceutical Manufacturing
Xp Pharma Consulting, Llc's top competitors are
Solutio Indústria Química,
Fargimed,
Corvus Pharmaceuticals,
Farmoterápica,
Phd - Pharma Dermacosmetics Ltd.,
Dioxide Indústria Química,
Nuventra Pharma Sciences,
Gene Therapy Program | University Of Pennsylvania,
Inovamed Hospitalar,
Sixty Pharma.
Xp Pharma Consulting, Llc's categories are Pharmaceutical Manufacturing
Xp Pharma Consulting, Llc's founding year is 2019
