| 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 |
| Biomarkers of Acute Kidney Injury | | 2010 |
| Quantitative disease, drug, and trial models | Annual Review of Pharmacology and Toxicology | 2009 |
| Regulatory Environment | | 2009 |
| Bringing toxicology into the 21st century: a global call to action | Toxicology in Vitro | 2009 |
| A review of imaging agent development | AAPS Journal | 2009 |
| Evaluating potential benefits of dose-exposure-response modeling for dose finding | Pharmaceutical Statistics | 2009 |
| Adaptive designs for confirmatory clinical trials | Statistics in Medicine | 2009 |
| Phase 0 clinical trials in oncology: a paradigm shift for early drug development? | Cancer Chemotherapy and Pharmacology | 2009 |
| [Supportive and adjunctive sepsis therapy] | Der Internist | 2009 |
| Tarsal and metatarsal bone mineral density measurement using volumetric quantitative computed tomography | Journal of Digital Imaging | 2009 |
| Literature mining on pharmacokinetics numerical data: a feasibility study | Journal of Biomedical Informatics | 2009 |
| Exploratory drug safety: a discovery strategy to reduce attrition in development | Journal of Pharmacological and Toxicological Methods | 2009 |
| Biological Events | | |
| Introduction: PhRMA's Best Practices Initiative on FDA's Good Review Management Practices | Drug Information Journal | 2008 |
| Strategic approach to fit-for-purpose biomarkers in drug development | Annual Review of Pharmacology and Toxicology | 2008 |
| Strong correlation between serum aspergillus galactomannan index and outcome of aspergillosis in patients with hematological cancer: clinical and research implications | Clinical Infectious Diseases | 2008 |
| Chemical imaging of pharmaceutical materials: fabrication of micropatterned resolution targets | Analytical Chemistry | 2008 |
| Pharmacokinetic/pharmacodynamic modelling in diabetes mellitus | Clinical Pharmacokinetics | 2008 |
| Pharmacokinetic and pharmacodynamic data to be derived from early-phase drug development: designing informative human pharmacology studies | Clinical Pharmacokinetics | 2008 |
| Pharmacogenomics | Methods in Pharmacology and Toxicology | 2008 |
| Challenges, Opportunities, and Evolving Landscapes in Pharmacogenomics and Personalized Medicine | Methods in Pharmacology and Toxicology | 2008 |
| Pharmacokinetics and biological activity of atacicept in patients with rheumatoid arthritis | Journal of Clinical Pharmacology | 2008 |
| Contribution of the active metabolite M1 to the pharmacological activity of tesofensine in vivo: a pharmacokinetic-pharmacodynamic modelling approach | British Journal of Pharmacology | 2008 |
| Privatizing biomedical research--a 'third way' | Nature Biotechnology | 2008 |
| Accelerating drug development using biomarkers: a case study with sitagliptin, a novel DPP4 inhibitor for type 2 diabetes | AAPS Journal | 2008 |
| Dose finding - a challenge in statistics | Biometrical Journal | 2008 |
| Reply to Festing | BioEssays | 2008 |
| Toward quantitative fluorescence measurements with multicolor flow cytometry | Cytometry Part A: the Journal of the International Society for Analytical Cytology | 2008 |
| Software sensors for fermentation processes | Bioprocess and Biosystems Engineering | 2008 |
| The translational path includes the FDA's critical path | Journal of Cardiovascular Translational Research | 2008 |
| Equivalence-by-design: targeting in vivo drug delivery profile | Pharmaceutical Research | 2008 |
| Effective integration of systems biology, biomarkers, biosimulation and modelling in streamlining drug development | European Journal of Pharmaceutical Sciences | 2007 |
| Promises of biomarkers in drug development--a reality check | Chemical Biology and Drug Design | 2007 |
| Publication of a negative trial without disclosing the drug | Alimentary Pharmacology and Therapeutics | 2007 |
| The FDA animal efficacy rule and biodefense | Nature Biotechnology | 2007 |
| Bayesian predictive power for interim adaptation in seamless phase II/III trials where the endpoint is survival up to some specified timepoint | Statistics in Medicine | 2007 |
| Analysis of progression-free survival in oncology trials: some common statistical issues | Pharmaceutical Statistics | 2007 |
| Comparisons of optical pH and dissolved oxygen sensors with traditional electrochemical probes during mammalian cell culture | Biotechnology and Bioengineering | 2007 |
| Chiral Drug Discovery and Development – From Concept Stage to Market Launch | | 2007 |
| Exploratory IND: a new regulatory strategy for early clinical drug development in the United States | Ernst Schering Research Foundation Workshop | 2007 |
| Drug eluting stents and the critical path initiative: Evolving paradigms for safety evaluation | Drug Discovery Today: Technologies | 2007 |
| Integrated pharmacokinetics and pharmacodynamics in drug development | Clinical Pharmacokinetics | 2007 |
| The Impact of the Web and Standards on Clinical Trials | Pharmaceutical Medicine | 2007 |
| 19th Annual Drug Information Association (DIA) EuroMeeting | Pharmaceutical Medicine | 2007 |
| A Regulatory Perspective on Validation of Surrogate Endpoints | Drug Information Journal | 2007 |
| Dose Finding Studies | | 2007 |
| A retrospective analysis of toxicogenomics in the safety assessment of drug candidates | Toxicologic Pathology | 2007 |
| Enabling Technologies in Drug Discovery: The Technical and Cultural Integration of the New with the Old | | 2007 |
| Regulatory perspective on clinical trials and end points for female sexual dysfunction, in particular, hypoactive sexual desire disorder: formulating recommendations in an environment of evolving clinical science | International Journal of Impotence Research | 2007 |
| Toxicogenomics in risk assessment: applications and needs | Toxicological Sciences | 2006 |
