The current role of model-based drug development

Suryawanshi, Satyendra; Zhang, Liping; Pfister, Marc

doi:10.1517/17460441003713470

Cited by 30 publications

(23 citation statements)

References 42 publications

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“…The characterization of the PK/PD relationship of investigational drugs is one major area in drug development where different modelbased concepts and procedures are widely applied [66]. This includes therapeutic proteins [67].…”

Section: Expert Opinionmentioning

confidence: 99%

Tools for predicting the PK/PD of therapeutic proteins

Diao

2015

Expert Opinion on Drug Metabolism & Toxicology

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A variety of state-of-the-art PK/PD tools is currently being applied and has been adjusted to support the development of proteins as therapeutics, including allometric scaling approaches, target-mediated disposition models, first-in-man dose calculations, physiologically based PK models and empirical and semi-mechanistic PK/PD modeling. With the advent of the next generation of biologics including bioengineered antibody constructs being developed, these tools will need to be further refined and adapted to ensure their applicability and successful facilitation of the drug development process for these novel scaffolds.

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Section: Expert Opinionmentioning

confidence: 99%

Tools for predicting the PK/PD of therapeutic proteins

Diao

2015

Expert Opinion on Drug Metabolism & Toxicology

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“…The application of pharmacometric analyses using PK/PD based M&S approaches has in the recent decade developed into one of the most essential tools for interpreting and integrating large and diverse pools of preclinical and clinical data and translating them into an informative knowledgebase [5]. It is expedient not only for industry professionals to promote internal decision making at critical drug development steps, but is also increasingly utilized by regulatory authorities for compiling and analyzing data for approval and labeling.…”

Section: The Determination Of Pk/pd Indices and Susceptibility Breakpmentioning

confidence: 99%

“…Data and information from various sources are bridged together and quantitatively related to each other. Computer-based modeling and simulation of pharmacokinetic (PK) and pharmacodynamic (PD) data (denoted as PK/PD M&S) usually forms the basis for a pharmacometric analysis, but is frequently supplemented by models characterizing important other aspects of drug efficacy and/or safety in a given situation, such as disease progression, adherence to therapy or bacterial growth and infection [5]. PD measures used in pharmacometrics are frequently biomarkers, but can also be surrogate endpoints or clinical endpoints.…”

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confidence: 99%

Applications of pharmacometrics in the clinical development and pharmacotherapy of anti-infectives

Trivedi

Lee

2013

Expert Review of Clinical Pharmacology

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With the increased emergence of anti-infective resistance in recent years, much focus has recently been drawn to the development of new anti-infectives and the optimization of treatment regimens and combination therapies for established antimicrobials. In this context, the field of pharmacometrics using quantitative numerical modeling and simulation techniques has in recent years emerged as an invaluable tool in the pharmaceutical industry, academia and regulatory agencies to facilitate the integration of preclinical and clinical development data and to provide a scientifically based framework for rationale dosage regimen design and treatment optimization. This review highlights the usefulness of pharmacometric analyses in anti-infective drug development and applied pharmacotherapy with select examples.

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“…The current imperfect acceptance of MBDD is partially caused by the natural maturation of pharmacometrics as a new scientific discipline and is partially the result of our own conduct 5 . Differentiating the stakeholders by their acceptance levels and targeting each level with the right tactics can be an effective way to bring key stakeholders closer to level 4 7 . Investment in time and resources to promote MBDD is necessary.…”

Section: Fostering Culture That Primes For Mbddmentioning

confidence: 99%

Fostering Culture and Optimizing Organizational Structure for Implementing Model‐Based Drug Development

Zhang¹,

Allerheiligen²,

Lalonde³

et al. 2010

The Journal of Clinical Pharma

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Model-based drug development (MBDD) is a promising approach to improve decision making in drug development. The pharmaceutical industry has made substantial progress from engaging in empirical decision making to increasingly using pharmacometrics (ie, modeling and simulation [M&S]) as a quantitative decision-making tool. Focusing on culture and an organizational structure perspective, this commentary summarizes experiences and vision from industry M&S leaders on implementing MBDD. A culture for MBDD needs to have wide acceptance of MBDD, enhanced decision making with probability-based evidence and transparent rationale, quantitative impact metrics, and a brand that emphasizes cross-disciplinary collaboration and ownership. An organizational structure for MBDD needs to have a dedicated pharmacometrics function, fine balance between quick wins and impact on long-term R&D goals, and collaborative MBDD teams among clinical pharmacologists, statisticians, pharmacometricians, and clinicians. Pharmaceutical companies with these characteristics are prepared to fully embrace and implement MBDD.

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The current role of model-based drug development

Abstract: MBDD is a tool that is increasingly used throughout the drug discovery and development continuum to support fast and rationale decision making and has thereby the potential to accelerate and increase the cost-effectiveness of the drug development process.

Cited by 30 publications

References 42 publications

Tools for predicting the PK/PD of therapeutic proteins

Tools for predicting the PK/PD of therapeutic proteins

Applications of pharmacometrics in the clinical development and pharmacotherapy of anti-infectives

Fostering Culture and Optimizing Organizational Structure for Implementing Model‐Based Drug Development

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