| Facilitating treatment initiation and reproductive care postpartum to prevent substance-exposed pregnancies: A randomized bayesian pilot trial | | 2022 |
| The Application of PK/PD Modeling and Simulations During Lead Optimization | | 2006 |
| Clinical drug evaluation using imaging readouts: regulatory perspectives | Progress in Drug Research Fortschritte Der Arzneimittelforschung Progres Des Recherches Pharmaceutiques | 2005 |
| “MIST” AND OTHER METABOLITE GUIDELINES IN THE CONTEXT OF INDUSTRIAL DRUG METABOLISM | | |
| Validation des biomarqueurs, niveau de preuve et essais cliniques adaptatifs | | 2014 |
| Implementing Systems Toxicology in Drug Development for Regulatory Decision Making | | |
| Modeling the Progression of Disease | | 2011 |
| Role of the US Food and Drug Administration in Cancer Drug Development | | 2011 |
| Optimizing the Use of Biomarkers for Drug Development: A Clinician's Perspective | | |
| Future Challenges in Design and Ethics of Clinical Trials | | |
| Strategies for the Co-Development of Drugs and Diagnostics: FDA Perspective on Diagnostics Regulation | | |
| Absorption Models to Examine Bioavailability and Drug–Drug Interactions in Humans | | 2010 |
| Role of Pharmacogenomics in Drug Development | | 2009 |
| Pharmacogenomics in Drug Development: A Pharmaceutical Industry Perspective | | 2008 |
| The Role of Mass Spectrometry for Safety Evaluation in the Drug Discovery Stage | Journal of the Mass Spectrometry Society of Japan | 2008 |
| Types of Clinical Studies | | 2007 |
| Regulatory Guidance and Validation of Toxicologic Biomarkers | | 2006 |
| Enabling Semantic Web Inferencing with Oracle Technology: Applications in Life Sciences | Lecture Notes in Computer Science | 2005 |
| From Sequence to Genomic Medicine: Genome Policy Considerations | | 2009 |
| Agent-Based Modeling Approaches to Multi-Scale Systems Biology: An Example Agent-Based Model of Acute Pulmonary Inflammation | | 2013 |
| Can cell systems biology rescue drug discovery? | Ernst Schering Research Foundation Workshop | 2007 |
| Bayesian Interim Inference of Probability of Clinical Trial Success | Springer Proceedings in Mathematics and Statistics | 2013 |
| Biomarkers: Facing the Challenges at the Crossroads of Research and Health Care | | |
| Phase 0/microdosing approaches: time for mainstream application in drug development? | Nature Reviews Drug Discovery | 2020 |
| Adaptive trial designs for spinal cord injury clinical trials directed to the central nervous system | Spinal Cord | 2020 |
| Application of Proteomic Approaches to Accelerate Drug Development for Psychiatric Disorders | Advances in Experimental Medicine and Biology | 2017 |
| Application of Multiplex Biomarker Approaches to Accelerate Drug Discovery and Development | Methods in Molecular Biology | 2017 |
| [Multidrug-resistant bacteria in Germany. The impact of sources outside healthcare facilities] | Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz | 2016 |
| Adaptive design of confirmatory trials: Advances and challenges | Contemporary Clinical Trials | 2015 |
| Catalyzing the Critical Path Initiative: FDA's progress in drug development activities | Clinical Pharmacology and Therapeutics | 2015 |
| Dose Finding Studies | | 2014 |
| Sample Size Reestimation for Confirmatory Clinical Trials | | 2012 |
| Agent-based modeling and biomedical ontologies: a roadmap | Wiley Interdisciplinary Reviews: Computational Statistics | 2011 |
| Serum cancer biomarker discovery through analysis of gene expression data sets across multiple tumor and normal tissues | Journal of Biomedical Informatics | 2011 |
| Bridging the translation gap - new hopes, new challenges | Fundamental and Clinical Pharmacology | 2011 |
| Microdialysis Versus Imaging Techniques for In Vivo Drug Distribution Measurements | | 2011 |
| The Application of Drug-Disease Models in the Development of Anti-Hyperglycemic Agents | AAPS Advances in the Pharmaceutical Sciences Series | 2011 |
| Improving toxicity screening and drug development by using genetically defined strains | Methods in Molecular Biology | 2010 |
| Overview on the Rule of Five | Current Protocols in Pharmacology | 2010 |
| Genome Policy Considerations for Genomic Medicine | | 2010 |
| Economic opportunities and challenges for pharmacogenomics | Annual Review of Pharmacology and Toxicology | 2010 |
| Preclinical Drug Development Planning | | 2010 |
| Visualizing the landscape of selection biomarkers in current phase III oncology clinical trials | Science Translational Medicine | 2010 |
| The Principles of ICH S6 and the Case-by-Case Approach | | 2010 |
| Likelihood inference for a two-stage design with treatment selection | Biometrical Journal | 2010 |
| The future of drug discovery and development: Shifting emphasis towards personalized medicine | Technological Forecasting and Social Change | 2010 |
| Impact of biomarker development on drug safety assessment | Toxicology and Applied Pharmacology | 2010 |
| Toxicogenomic profiling of chemically exposed humans in risk assessment | Mutation Research - Reviews in Mutation Research | 2010 |
| Ruthenium-based chemotherapeutics: are they ready for prime time? | Cancer Chemotherapy and Pharmacology | 2010 |
| Successes achieved and challenges ahead in translating biomarkers into clinical applications | AAPS Journal | 2010 |
