Company Profile

MJB Pharma Consulting, Inc

Company Overview

The evaluation of pharmacokinetic parameters is an essential part of understanding how drugs function in the body. To estimate these parameters, time-dependent (PK) samples are collected throughout your clinical studies. These samples are used to generate the pharmacokinetic parameters by noncompartmental methods (NCA). The full prescribing information of the USPI consists of 17 sections, of which 9 are supported by pharmacokinetic data obtained from your Clinical studies.

With 20 years of drug discovery and development experience, Michael Bargfrede (Principle) provides high-quality clinical PK/PD noncompartmental analyses and interpretation to support real-time decision making at every stage of your programs development. MJB Pharma Consulting will support you through the dynamic landscape of drug development, adapting to your business needs and providing quick, thorough turnarounds of analyses for dose escalation meetings, unexpected adverse events, or whatever the challenges of drug development throws at you. Reporting options that range from PK memos to submission ready PK reports and scientific manuscript preparation. Michael’s experience spans many therapeutic areas including oncology, gastrointestinal, inflammation, CNS and immunology as well as small molecule, monoclonal antibody and antibody drug conjugate therapeutic applications.

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