The determination and interpretation of the therapeutic index in drug development

In silicomodels for drug-induced liver injury – current status

(2012) Katarzyna R Przybylak et al.   Expert Opinion on Drug Metabolism & Toxicology

Proteomics in the search for mechanisms and biomarkers of drug-induced hepatotoxicity

(2012) Anke Van Summeren et al.   TOXICOLOGY IN VITRO

α4β2 neuronal nicotinic receptor positive allosteric modulation: An approach for improving the therapeutic index of α4β2 nAChR agonists in pain

(2011) Chih-Hung Lee et al.   BIOCHEMICAL PHARMACOLOGY

On the relationship between block of the cardiac Na+channel and drug-induced prolongation of the QRS complex

(2011) AR Harmer et al.   BRITISH JOURNAL OF PHARMACOLOGY

Drug Safety Sciences and the Bottleneck in Drug Development

(2011) P B Watkins   CLINICAL PHARMACOLOGY & THERAPEUTICS

Imatinib mesylate for the treatment of pulmonary arterial hypertension

(2011) Henrik ten Freyhaus et al.   EXPERT OPINION ON INVESTIGATIONAL DRUGS

Managing the challenge of chemically reactive metabolites in drug development

(2011) B. Kevin Park et al.   NATURE REVIEWS DRUG DISCOVERY

Comparative requirements for exploratory clinical trials — eIND, eCTA and microdosing

(2010) Patrick Y. Muller   ADVANCED DRUG DELIVERY REVIEWS

Permitting Product Liability Litigation for FDA-Approved Drugs and Devices Promotes Patient Safety

(2010) A S Kesselheim   CLINICAL PHARMACOLOGY & THERAPEUTICS

Native albumin for targeted drug delivery

(2010) Elena Neumann et al.   Expert Opinion on Drug Delivery

The effect of plasma protein binding on in vivo efficacy: misconceptions in drug discovery

(2010) Dennis A. Smith et al.   NATURE REVIEWS DRUG DISCOVERY

Membrane transporters in drug development

(2010)   NATURE REVIEWS DRUG DISCOVERY

Use of transcriptomics in understanding mechanisms of drug-induced toxicity

(2010) Yuxia Cui et al.   PHARMACOGENOMICS

The use of Cav rather than AUC in safety assessment

(2010) D.A. Smith et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Autoradiography, MALDI-MS, and SIMS-MS Imaging in Pharmaceutical Discovery and Development

(2009) Eric G. Solon et al.   AAPS Journal

Safety Assessment and Dose Selection for First-in-Human Clinical Trials With Immunomodulatory Monoclonal Antibodies

(2009) PY Muller et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

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

Genomic and proteomic approaches for predicting toxicity and adverse drug reactions

(2009) Feng Ge et al.   Expert Opinion on Drug Metabolism & Toxicology

Tissue-specific, non-invasive toxicity biomarkers: translation from preclinical safety assessment to clinical safety monitoring

(2009) Patrick Y Muller et al.   Expert Opinion on Drug Metabolism & Toxicology

In vitrosafety pharmacology profiling: what else beyond hERG?

(2009) Jacques Hamon et al.   Future Medicinal Chemistry

Concentration-dependent plasma protein binding of the novel dipeptidyl peptidase 4 inhibitor BI 1356 due to saturable binding to its target in plasma of mice, rats and humans

(2009) Holger Fuchs et al.   JOURNAL OF PHARMACY AND PHARMACOLOGY

Translation between in vitro inhibition of the cardiac Nav1.5 channel and pre-clinical and clinical QRS widening

(2009) Jason Cordes et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS