Assisting You in All Stages of Drug Development

XP Pharma Consulting provides Clinical Pharmacology & PK/PD services.

XP Pharma Consulting provides expert services to your drug development program through the lens of clinical pharmacology, pharmacokinetics, and pharmacometrics (modeling and simulation) to maximize the impact of each study on the overall development program in all phases of drug development.

Testimonials

Clinical Pharmacology Strategy and Writing: “I enjoy working with XP Pharma Consulting. They can manage all aspects of clinical pharmacology projects. For example, XP Pharma supported us in the assessment of drug-drug interactions, integrated non-clinical and clinical evaluation of QT prolongation potential, application for a thorough QT study waiver, design of clinical pharmacology studies, interpretation of population PK and PK/PD modeling results, and scientific writing for regulatory documents”.

Senior Director-Clinical Pharmacology, Pharma Client

Population PK/PD Modeling &Simulation: “XP Pharma has played a significant role in supporting the early clinical development programs of two of our novel molecules. XP Pharma’s PK assessments and modeling have provided us with important information that has helped us to determine safe and optimal dosing and dosing regimens for our Phase 1 and 2 clinical trials”.

Executive Director ‐ Clinical Development, Pharma Client

Clinical Pharmacology Studies: “XP Pharma Consulting’s knowledge of FDA requirements around clinical pharmacology (drug‐drug interaction studies, CYP450 interaction studies) has helped us to design our Clinical Development plans more accurately by allowing us to incorporate these NDA required studies optimally”.

Executive Director ‐ Clinical Development, Pharma Client

Timely and Detailed Analysis. “XP Pharma is available on short notice and provides timely and detailed analyses. We continue to work closely with XP Pharma as our clinical development programs move forward”.

Executive Director ‐ Clinical Development, Pharma Client

Leading Edge Clinical Pharmacology Support: “XP Pharma Consulting provided leading edge clinical pharmacology and development advice and services that led to several successful IND approvals and the implementation of several clinical development programs. They have also assisted us on translational research programs at pre-IND to IND stage using state-of-the-art modeling and simulation tools”.

Director. Clinical Development, Pharma Client

“High Quality and High Science Plans: Dr. Zhang and her team engaged early and provided rapid, high quality, high science plans and analyses. We really appreciate all of their hard work and advice to our development program. We look forward to continued collaboration and hopefully more regulatory IND and NDA approvals in the months and years to come”.

Director. Clinical Development, Pharma Client

Pre-IND to IND

XP Pharma Consulting works with you to estimate starting doses and dose ranges for the first-in-human trials. We offer following services:

Noncompartmental PK/PD/TK

  • Noncompartmental analysis
  • Submission-ready study reports

Population PK/PD Modeling & Simulation

  • Allometric scaling
  • Dose selection and justification
  • Study design simulations
  • Human exposure prediction
  • Human PK/PD simulation

Clinical Pharmacology Strategy & Writing

  • Gap analyses/Question Based Review (QBR)
  • Clinical pharmacology plans
  • Clinical study designs
  • Study protocols (in full or in part) and reviews
  • Study reports (in full or in part) and reviews
  • Regulation documents preparation (PK/PD)
  • IND study protocol authoring (in full or in part) and reviews
  • Clinical development plans (in full or in part) and reviews
  • Responses to regulatory questions (in full or in part) and reviews
  • Comparator PK/PD data analyses

Early Phase

XP Pharma Consulting works with you to create plans to ensure that each study fits with your overall drug development program and facilitates efficient and timely data generation, analysis, and reporting. We offer the following services:

Noncompartmental PK/PD/TK

  • Noncompartmental analysis
  • Submission-ready study reports

Population PK/PD Modeling & Simulation

  • Population PK analysis
  • PK exposure-response (E-R) analysis
  • Concentration -QT analysis and modeling
  • Dose selection and justification
  • Study design simulations

Clinical Pharmacology Strategy & Writing

  • Gap analyses/Question Based Review (QBR)
  • Clinical pharmacology plan
  • Assessment of DDI potential
  • Assessment of QT prolongation potential
  • Clinical study designs
  • Study protocol (in full or in part) and review
  • Study report (in full or in part) and review
  • Regulation documents preparation (PK/PD)
  • Regulatory meeting representations
  • Comparator PK/PD data analysis
  • Clinical Pharmacology Studies
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Late Phase

You have successfully completed several early phase studies. Now XP Pharma Consulting works with you utilizing quantitative tools and strategies that facilitate successful data interpretation and reporting. We help you design pivotal studies that will generate the PK/PD data required to secure a successful clinical pharmacology package for NDA/BLA filing. We employ innovative modeling and simulation techniques to justify the doses in the labeling, avoid certain late-phase studies, build a bridge strategy to pediatric
populations, simulate clinical studies under different scenarios, and more:

Clinical Pharmacology Strategy & Writing

  • Gap analyses/Question Based Review (QBR)
  • Study protocol (in full or in part) and review
  • Study report (in full or in part) and review
  • Assess need for DDI studies
  • Determine TQT waivers and prepare application packages
  • Assess a need for a thorough QT (TQT) study
  • Author TQT study waiver (in full or in part)
  • Pediatric dose determination for PIP and PSP
  • Regulation documents preparation (PK/PD)
  • Regulatory meeting representations
  • Conduct comparator PK/PD data analyses

Noncompartmental PK/PD/TK

  • Noncompartmental analysis
  • Submission-ready study reports

Population PK Modeling & Simulation

  • Population PK analysis
  • PK exposure-response (E-R) analysis
  • Concentration -QT analysis and modeling
  • Dose selection and justification
  • Study design simulations
  • Comparator PK/PD analyses
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Clinical Pharmacology Studies

Clinical pharmacology studies are necessary for understanding the PK and PD properties of your drug. XP Pharma Consulting works with you to evaluate regulatory feedback and available data to identify the necessary studies. XP Pharma Consulting can assist in generating the study design, synopsis, and protocol for trials of following types:

  • First-in-human (FIH)
  • Single ascending dose (SAD)
  • Multiple ascending doses (MAD)
  • Bioequivalence
  • Relative bioavailability
  • Food effects
  • Drug-drug interactions (DDI)
  • Thorough QT (TQT)
  • Pediatric PK/PD bridging to adult dose study
  • PK in hepatic-impaired subjects
  • PK in renal-impaired subjects
  • Radio-labeled mass balance (ADME and metabolic profiling)
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NDA/BLA Filing

You have successfully completed early-phase and late-phase clinical studies after significant investment. Now XP Pharma Consulting works with you to prepare NDA/BLA submissions and ancillary materials and documentation.

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Regulatory Writing & Strategy

  • Integrated PK and PK/PD analyses and reports
  • NDA/BLA (CTD modules 2.7.1 and 2.7.2)
  • PK and PD sections of the label
  • Integrated immunogenicity analyses and reports
  • Responses to questions in the review period
  • Regulatory representation
  • Ad hoc PK/PD analyses
  • Manuscripts, posters, conference presentations