Clinical pharmacology considerations in biologics development

Metabolism of biologics: biotherapeutic proteins

(2012) Lora L Hamuro et al.   Bioanalysis

From Target Selection to the Minimum Acceptable Biological Effect Level for Human Study: Use of Mechanism-based PK/PD Modeling to Design Safe and Efficacious Biologics

(2011) Jing Yu et al.   AAPS Journal

Therapeutic Index of Anticoagulants for Prevention of Venous Thromboembolism Following Orthopedic Surgery: A Dose–Response Meta-Analysis

(2011) J W Mandema et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Model-Based Meta-Analysis for Comparative Efficacy and Safety: Application in Drug Development and Beyond

(2011) J W Mandema et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

A Dose–Response Meta-Analysis for Quantifying Relative Efficacy of Biologics in Rheumatoid Arthritis

(2011) J W Mandema et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Fixed Dosing Versus Body Size-Based Dosing of Therapeutic Peptides and Proteins in Adults

(2011) Shuzhong Zhang et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Therapeutic Protein–Drug Interactions and Implications for Drug Development

(2010) S-M Huang et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

A new stochastic approach to multi-compartment pharmacokinetic models: probability of traveling route and distribution of residence time in linear and nonlinear systems

(2010) Liang Zhao et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Decreased clinical response to adalimumab in ankylosing spondylitis is associated with antibody formation

(2009) M K de Vries et al.   ANNALS OF THE RHEUMATIC DISEASES

The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies

(2009) Patrick Y Muller et al.   CURRENT OPINION IN BIOTECHNOLOGY

Fixed Dosing Versus Body Size-Based Dosing of Monoclonal Antibodies in Adult Clinical Trials

(2009) Diane D. Wang et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Physiologically-Based PK/PD Modelling of Therapeutic Macromolecules

(2009) Peter Thygesen et al.   PHARMACEUTICAL RESEARCH

Monoclonal Antibody Pharmacokinetics and Pharmacodynamics

(2008) W Wang et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS