XP Pharma Consulting is a service provider that specializes in the design and implementation of clinical pharmacology-guided drug development strategies across various therapeutic areas, from early to late development and through registration.
XP Pharma Consulting uses pharmacokinetics (PK), pharmacodynamics (PD), and PK/PD modeling and simulation (M&S) techniques to advance the understanding of drug properties, enhancing informed decision-making by the client at each stage of drug development.
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”.
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”.
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”.
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”.
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”.
“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”.
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