Challenges and considerations for development of therapeutic proteins in pediatric patients

Understanding dosing: children are small adults, neonates are immature children

(2013) B. J. Anderson et al.   ARCHIVES OF DISEASE IN CHILDHOOD

Immunogenicity to Therapeutic Proteins: Impact on PK/PD and Efficacy

(2012) Narendra Chirmule et al.   AAPS Journal

Evaluation of a Catenary PBPK Model for Predicting the In Vivo Disposition of mAbs Engineered for High-Affinity Binding to FcRn

(2012) Yang Chen et al.   AAPS Journal

Pharmacokinetic and Pharmacodynamic Properties of Canakinumab, a Human Anti-Interleukin-1β Monoclonal Antibody

(2012) Abhijit Chakraborty et al.   CLINICAL PHARMACOKINETICS

A Guide to Rational Dosing of Monoclonal Antibodies

(2012) Shuang Bai et al.   CLINICAL PHARMACOKINETICS

Physiologically Based Pharmacokinetic (PBPK) Modeling in Children

(2012) J S Barrett et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Regulatory Experience With Physiologically Based Pharmacokinetic Modeling for Pediatric Drug Trials

(2012) R Leong et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Disposition and Interaction of Biotherapeutics in Pediatric Populations

(2012) Souzan Yanni   CURRENT DRUG METABOLISM

Safety and Efficacy of Adalimumab for Moderate to Severe Crohn's Disease in Children

(2012) Jeffrey S. Hyams et al.   GASTROENTEROLOGY

Rational development and utilization of antibody-based therapeutic proteins in pediatrics

(2012) Zhenhua Xu et al.   PHARMACOLOGY & THERAPEUTICS

Pharmacokinetic Properties of Infliximab in Children and Adults with Crohn's Disease: A Retrospective Analysis of Data from 2 Phase III Clinical Trials

(2011) Adedigbo A. Fasanmade et al.   CLINICAL THERAPEUTICS

Three years of paediatric regulation in the European Union

(2011) Thorsten M. Olski et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Clarification on Precision Criteria to Derive Sample Size When Designing Pediatric Pharmacokinetic Studies

(2011) Yaning Wang et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Towards a platform PBPK model to characterize the plasma and tissue disposition of monoclonal antibodies in preclinical species and human

(2011) Dhaval K. Shah et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Pediatric Dose Selection

(2010) D R Abernethy et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Have we overestimated the benefit of human(ized) antibodies?

(2010) Daniel R. Getts et al.   mAbs

Drug Development for Pediatric Populations: Regulatory Aspects

(2010) Jochen Zisowsky et al.   Pharmaceutics

Mechanistic Basis of Using Body Size and Maturation to Predict Clearance in Humans

(2009) Brian J. Anderson et al.   Drug Metabolism and Pharmacokinetics

Phase I and Pharmacokinetic Study of Cetuximab and Irinotecan in Children With Refractory Solid Tumors: A Study of the Pediatric Oncology Experimental Therapeutic Investigators' Consortium

(2009) Tanya M. Trippett et al.   JOURNAL OF CLINICAL ONCOLOGY

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 pharmacokinetic model for T84.66: A monoclonal anti-CEA antibody

(2009) Shweta R. Urva et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Phase I Trial and Pharmacokinetic Study of Bevacizumab in Pediatric Patients With Refractory Solid Tumors: A Children's Oncology Group Study

(2008) Julia L. Glade Bender et al.   JOURNAL OF CLINICAL ONCOLOGY

Safety and pharmacokinetics of daclizumab in pediatric renal transplant recipients

(2007) Mark D. Pescovitz et al.   PEDIATRIC TRANSPLANTATION