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#Winnonlin for pk professional#
Clinical Study Report Writing and Protocol Writing Qualified Scientists performing PK/PD Analyses and Report Writingġ) Non-Compartmental PK/PD analysis using WinNonlin ® and AutoPilot™ PK and PD analyses and creation of Tables, Figures and Listings Statistical analyses (ANOVAs, Dose-Proportionality, Steady-State Analysis) Draft and Final ICHE3 Clinical Study Reports PK/PD Analysis and Report 100% QC’d by two scientists (Authenticator and Reviewer) QA inspection performed by a Registered Quality Assurance Professional in GLPs (RQAP-GLP). Sciences, Toxicology, Pharmacy Non-compartmental, modeling and simulations, covariate analysis… Technical training with industry‑leading software.
#Winnonlin for pk software#
How Can RAS Help You? WinNonlin ® & AutoPilot™ for Noncompartmental Analysis WinNonlin ® IVIVC Toolkit Time of Analysis Quality Assurance (QA) - Validated Software Standard Operating Procedure (SOP) (Internal/External) 21 CFR Part 11 Compliance Regulatory Compliance Experienced & Qualified Scientists Graduate degree in Pharm. PK/PD Expertise in Early Drug Development Where Is Our Strategic Focus? We provide tools and services that help our customers increase drug development efficiency, with a particular focus on the decisions occurring within the FDA’s “critical path.” 5000 250 5 1 Discovery Pre-Clinical Clinical Approval $23B 1 Dimasi, et al, 'The price of innovation: new estimates of drug development costs,' Journal of Health Economics, 22:2, March 2PAREXEL R&D Statistical Sourcebook from Bain and In VEstimated Global Pharma and Biotech R&D Spending by Category: BioPharm International, March 2003 4 PhRMA 2003 Industry Profile, March 2003 $48B The Critical Path except where noted all numbers are estimates for industry totals per year 3,4 Average time and cost per approved compound:8 years and $524M 1,2 Who Are Pharsight Customers? This is a sample from Pharsight's customer base which includes all Top 50 Pharmaceutical companies. Outsource PK/PD Analysis and Clinical Study Report Writing Training A variety of courses teaching Pharsight software tools and model-based drug development skills. Understand the competitive landscape PK/PD Reporting and Analysis Services (RAS) High quality NCA, Population PK/PD Analysis and Reporting. Quantify your decision-making Metadata Modeling-ready data sets complied by experts from public source medical & scientific literature. Improve productivity and compliance Strategic Consulting Services (SCS) Consulting expertise in model-based drug development and decision-making. What Are Pharsight Capabilities? One theme: Efficient Drug Development Software Enterprise and desktop products for analyzing, presenting and storing drug development data. Reimer, PhD Senior Director Reporting and Analysis Services Pharsight Corporation PK/PD Reporting and Analysis Services (RAS) January 2009 Mark L.J.