XP Pharma Consulting works with you to translate preclinical DMPK, toxicology and pharmacology data to clinical study design for IND opening study. We offer following services:
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:
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 pediatricpopulations, simulate clinical studies under different scenarios, and more:
Clinical pharmacology studies are necessary for characterizing the PK and PD properties of your drug and needed for dosing instruction in the label. XP Pharma Consulting works with you to identify the necessary studies based on available clinical and non-clinical data according to industry guidance documents. XP Pharma Consulting can assist in study design, protocol authoring, PK/PD data analysis, study monitoring, and study reporting for trials of following types:
Pediatric and Elderly
You have successfully completed early-phase and late-phase clinical studies after significant investment. XP Pharma Consulting works with you to prepare clinical pharmacology portions of NDA/BLA submission documents, conduct necessary pooled analysis, and response to regulatory questions. We offer following services:
Noncompartmental PK analysis (NCA) is a standard method for calculating PK parameters. It is indispensable for characterizing PK within a single study and making time-critical dosing decisions for dose selection. XP Pharma Consulting can help you with your NCA analysis, data visualization, results interpretation, and high-quality reporting. We ensure you get the most out of your data, setting your program up for success. We offer following NCA services:
Regulatory agencies are responsible for approving all new drugs and for ensuring that all available drugs on the market are effective and safe for human use. Understanding the safety and effectiveness of any drug depends, in large part, on pharmacokinetics (PK), pharmacodynamics (PD), PK/PD modeling and simulation (M&S). Because of the growing emphasis placed on M&S analyses by regulatory authorities, and the wealth of information that these analyses provide, it is more important to consider where M&S can advance your drug development program. We offer following services:
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