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