Preclinical safety evaluations supporting pediatric drug development with biopharmaceuticals: strategy, challenges, current practices

Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies

(2010) Diane R. Mould et al.   BIODRUGS

Juvenile animal studies for the development of paediatric medicines: a description and conclusions from a European medicines agency workshop on juvenile animal testing for nonclinical assessors

(2010) Beatriz Silva-Lima et al.   BIRTH DEFECTS RESEARCH PART B-DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY

Population Pharmacokinetics of Therapeutic Monoclonal Antibodies

(2010) Nathanael L. Dirks et al.   CLINICAL PHARMACOKINETICS

The future of non-human primate use in mAb development

(2010) Kathryn L. Chapman et al.   DRUG DISCOVERY TODAY

Developmental Toxicity Testing of Biopharmaceuticals in Nonhuman Primates

(2010) Pauline L. Martin et al.   INTERNATIONAL JOURNAL OF TOXICOLOGY

Pediatric Dosing of Rituximab Revisited: Serum Concentrations in Opsoclonus-myoclonus Syndrome

(2010) Michael R. Pranzatelli et al.   JOURNAL OF PEDIATRIC HEMATOLOGY ONCOLOGY

Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies

(2010) Frank R. Brennan et al.   mAbs

Juvenile animal testing in drug development – Is it useful?

(2010) Paul Baldrick   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Understanding Developmental Pharmacodynamics

(2010) Hussain Mulla   PEDIATRIC DRUGS

Welfare of the minipig with special reference to use in regulatory toxicology studies

(2010) Lars Ellegaard et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Regulatory acceptability of the minipig in the development of pharmaceuticals, chemicals and other products

(2010) Jan Willem van der Laan et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

The utility of the minipig as an animal model in regulatory toxicology

(2010) Gerd Bode et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Ustekinumab: Lessons Learned from Targeting Interleukin-12/23p40 in Immune-Mediated Diseases

(2009) Michael Elliott et al.   Annals of the New York Academy of Sciences

Considerations in assessing the developmental and reproductive toxicity potential of biopharmaceuticals

(2009) Pauline L. Martin et al.   BIRTH DEFECTS RESEARCH PART B-DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY

Juvenile animal toxicity study designs to support pediatric drug development

(2009) Gregg D. Cappon et al.   BIRTH DEFECTS RESEARCH PART B-DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY

Comparison of Native E. coli and PEG Asparaginase Pharmacokinetics and Pharmacodynamics in Pediatric Acute Lymphoblastic Leukemia

(2009) J C Panetta et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Pharmacokinetics of Biotech Drugs: Peptides, Proteins and Monoclonal Antibodies

(2009) Jiunn Lin   CURRENT DRUG METABOLISM

Target-mediated drug disposition model: approximations, identifiability of model parameters and applications to the population pharmacokinetic–pharmacodynamic modeling of biologics

(2009) Leonid Gibiansky et al.   Expert Opinion on Drug Metabolism & Toxicology

Alternative Strategies for Toxicity Testing of Species-Specific Biopharmaceuticals

(2009) Jeanine L. Bussiere et al.   INTERNATIONAL JOURNAL OF TOXICOLOGY

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

Developmental immunotoxicology (DIT): windows of vulnerability, immune dysfunction and safety assessment

(2009) Rodney R. Dietert   Journal of Immunotoxicology

Immunotoxicity profile of natalizumab

(2009) Nancy G. Wehner et al.   Journal of Immunotoxicology

A comparison of effects on reproduction and neonatal development in cynomolgus monkeys given human soluble IL-4R and mice given murine soluble IL-4R

(2009) Linda L. Carlock et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Immunogenicity of biologically-derived therapeutics: Assessment and interpretation of nonclinical safety studies

(2009) Rafael Ponce et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Summary Comparison of Female Reproductive System in Human and the Cynomolgus Monkey (Macaca fascicularis)

(2009) Eric Van Esch et al.   TOXICOLOGIC PATHOLOGY

Clinical immunotoxicity of therapeutic proteins

(2008) Jacques Descotes et al.   Expert Opinion on Drug Metabolism & Toxicology

What’s So Special about the Developing Immune System?

(2008) Leigh Ann Burns-Naas et al.   INTERNATIONAL JOURNAL OF TOXICOLOGY

Plasma and albumin-free recombinant factorVIII: pharmacokinetics, efficacy and safety in previously treated pediatric patients

(2008) V. S. BLANCHETTE et al.   JOURNAL OF THROMBOSIS AND HAEMOSTASIS

Spontaneous and Age-Related Testicular Findings in Beagle Dogs

(2008) Michael J. Goedken et al.   TOXICOLOGIC PATHOLOGY

Measurement of immunological parameters in blood of Gottingen Minipigs® and the T cell-dependent immune response to KLH

(2008) Geertje van Mierlo et al.   TOXICOLOGY LETTERS

Mechanism-Based Concepts of Size and Maturity in Pharmacokinetics

(2007) B.J. Anderson et al.   Annual Review of Pharmacology and Toxicology