Nonclinical strategy considerations for safety pharmacology: evaluation of biopharmaceuticals

Preclinical Cardiovascular Safety Evaluations of Biologics

(2012) Luc Hondeghem et al.   BIODRUGS

The successes and limitations of preclinical studies in predicting the pharmacodynamics and safety of cell-surface-targeted biological agents in patients

(2012) Andrew G Polson et al.   BRITISH JOURNAL OF PHARMACOLOGY

Thirty years of preclinical safety evaluation of biopharmaceuticals: did scientific progress lead to appropriate regulatory guidance?

(2012) Marlous Kooijman et al.   Expert Opinion On Drug Safety

Comparison of arterial blood pressure measurements and hypertension scores obtained by use of three indirect measurement devices in hospitalized dogs

(2012) Morena B. Wernick et al.   JAVMA-JOURNAL OF THE AMERICAN VETERINARY MEDICAL ASSOCIATION

Marketed therapeutic antibodies compendium

(2012) Janice M. Reichert   mAbs

Cardiorespiratory safety evaluation in non-human primates

(2012) Jennifer L. Ingram-Ross et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Overview of global regulatory toxicology requirements for vaccines and adjuvants

(2012) Yuansheng Sun et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Comparison of non-invasive and implanted telemetric measurement of blood pressure and electrocardiogram in conscious beagle dogs

(2012) Gemma Ward et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Lung Function Measurements in Rodents in Safety Pharmacology Studies

(2012) Heinz Gerd Hoymann   Frontiers in Pharmacology

Taking immunogenicity assessment of therapeutic proteins to the next level

(2011) I.C. Büttel et al.   BIOLOGICALS

Concordance of preclinical and clinical pharmacology and toxicology of monoclonal antibodies and fusion proteins: soluble targets

(2011) Pauline L Martin et al.   BRITISH JOURNAL OF PHARMACOLOGY

Concordance of preclinical and clinical pharmacology and toxicology of therapeutic monoclonal antibodies and fusion proteins: cell surface targets

(2011) Peter J Bugelski et al.   BRITISH JOURNAL OF PHARMACOLOGY

Cardiovascular Function in Nonclinical Drug Safety Assessment

(2011) R. Dustan Sarazan et al.   INTERNATIONAL JOURNAL OF TOXICOLOGY

Boosting Brain Uptake of a Therapeutic Antibody by Reducing Its Affinity for a Transcytosis Target

(2011) Y. J. Yu et al.   Science Translational Medicine

Evaluation of D,L-SOTALOL (SOT) using jacketed external telemetry (JET) in conscious non-human primates (NHP) over 4weeks of evaluation

(2011) Hugo M. Vargas et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Integration of cardiovascular safety pharmacology endpoints into general toxicology studies

(2011) Robert A. Kaiser et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Evaluation of cardiac conduction disturbances using Jacketed External Telemetry (JET) in conscious Non-Human Primates (NHP)

(2011) Kathy Derakhchan et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Best practice in the conduct of key nonclinical cardiovascular assessments in drug development: Current recommendations from the Safety Pharmacology Society

(2011) D.J. Leishman et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Trends in Risks Associated With New Drug Development: Success Rates for Investigational Drugs

(2010) J A DiMasi et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Mechanisms of Drug Toxicity and Relevance to Pharmaceutical Development

(2010) F. Peter Guengerich   Drug Metabolism and Pharmacokinetics

A 4-Week Intrathecal Toxicity and Pharmacokinetic Study With Trastuzumab in Cynomolgus Monkeys

(2010) Angélique P. J. M. Braen et al.   INTERNATIONAL JOURNAL OF TOXICOLOGY

Biopharmaceutical drug targeting to the brain

(2010) William M. Pardridge   JOURNAL OF DRUG TARGETING

BeKm-1, a Peptide Inhibitor of Human ether-a-go-go-Related Gene Potassium Currents, Prolongs QTc Intervals in Isolated Rabbit Heart

(2010) Y. Qu et al.   JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS

Measurement of respiratory function using whole-body plethysmography in unanesthetized and unrestrained nonhuman primates

(2010) Hiromi Iizuka et al.   JOURNAL OF TOXICOLOGICAL SCIENCES

Preclinical development of monoclonal antibodies

(2010) Kathryn Chapman et al.   mAbs

Practical considerations for nonclinical safety evaluation of therapeutic monoclonal antibodies

(2010) Carmel M. Lynch et al.   mAbs

Metrics for antibody therapeutics development

(2010) Janice M. Reichert   mAbs

Experimental Infection of Cynomolgus Macaques (Macaca fascicularis) with Aerosolized Monkeypox Virus

(2010) Aysegul Nalca et al.   PLoS One

Evaluation of blood pressure measurement using a miniature blood pressure transmitter with jacketed external telemetry in cynomolgus monkeys

(2010) Carrie McMahon et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

An integrated cardiovascular and neurobehavioural functional assessment in the conscious telemetered cynomolgus monkey

(2010) Elena Moscardo et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Pulmonary toxicities of biologics: a review

(2009) Maajid Mumtaz Peerzada et al.   ANTI-CANCER DRUGS

Nonclinical development of biopharmaceuticals

(2009) Andreas Baumann   DRUG DISCOVERY TODAY

Challenges of general safety evaluations of biologics compared to small molecule pharmaceuticals in animal models

(2009) Rakesh Dixit et al.   Expert Opinion on Drug Discovery

High Definition Oscillometry: a novel technique for non-invasive blood pressure monitoring in the cynomolgus monkey (Macaca fascicularis)

(2009) B. Schmelting et al.   JOURNAL OF MEDICAL PRIMATOLOGY

Approaches to transport therapeutic drugs across the blood–brain barrier to treat brain diseases

(2009) Reinhard Gabathuler   NEUROBIOLOGY OF DISEASE

Respiratory safety pharmacology: Positive control drug responses in Sprague–Dawley rats, Beagle dogs and cynomolgus monkeys

(2009) Simon Authier 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

Comparison of electrocardiographic analysis for risk of QT interval prolongation using safety pharmacology and toxicological studies

(2009) B.D. Guth et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Assessment of two external telemetry systems (PhysioJacket™ and JET™) in beagle dogs with telemetry implants

(2009) Ray W. Chui et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Principles of Safety Pharmacology

(2008) M K Pugsley et al.   BRITISH JOURNAL OF PHARMACOLOGY

Safety Issues Specific to Clinical Development of Protein Therapeutics

(2008) CA Haller et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Species selection considerations for preclinical toxicology studies for biotherapeutics

(2008) Jeanine L Bussiere   Expert Opinion on Drug Metabolism & Toxicology

Safety-Related Regulatory Actions for Biologicals Approved in the United States and the European Union

(2008)   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Differential Effects of Dexamethasone on the Proximal and Distal Lung Response to Antigen Challenge in Allergic Cynomolgus Monkeys

(2008) Aidan K. Curran et al.   JOURNAL OF ASTHMA

Safety assessment of biopharmaceuticals: Japanese perspective on ICH S6 guideline maintenance

(2008) Takahiro Nakazawa et al.   JOURNAL OF TOXICOLOGICAL SCIENCES

Scientific review and recommendations on preclinical cardiovascular safety evaluation of biologics

(2008) Hugo M. Vargas et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

A functional observational battery in non-human primates for regulatory-required neurobehavioral assessments

(2008) David V. Gauvin et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Approval of new biopharmaceuticals 1999–2006: Comparison of the US, EU and Japan situations

(2007) K TSUJI   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS