1. Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation. Issue 4 (1st October 2019) Authors: Eichler, Hans‐Georg; Koenig, Franz; Arlett, Peter; Enzmann, Harald; Humphreys, Anthony; Pétavy, Frank; Schwarzer‐Daum, Brigitte; Sepodes, Bruno; Vamvakas, Spiros; Rasi, Guido Journal: Clinical pharmacology & therapeutics Issue: Volume 107:Issue 4(2020) Page Start: 773 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
2. Clinical Trials for COVID‐19: Can we Better Use the Short Window of Opportunity?. Issue 4 (12th June 2020) Authors: Eichler, Hans‐Georg; Cavaleri, Marco; Enzmann, Harald; Scotti, Francesca; Sepodes, Bruno; Sweeney, Fergus; Vamvakas, Spiros; Rasi, Guido Journal: Clinical pharmacology & therapeutics Issue: Volume 108:Issue 4(2020) Page Start: 730 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
3. Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease. Issue 4 (1st July 2014) Authors: Hill, Derek L.G.; Schwarz, Adam J.; Isaac, Maria; Pani, Luca; Vamvakas, Spiros; Hemmings, Robert; Carrillo, Maria C.; Yu, Peng; Sun, Jia; Beckett, Laurel; Boccardi, Marina; Brewer, James; Brumfield, Martha; Cantillon, Marc; Cole, Patricia E.; Fox, Nick; Frisoni, Giovanni B.; Jack, Clifford; Kelle... Journal: Alzheimer's & dementia Issue: Volume 10:Issue 4(2014) Page Start: 421 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
4. Data Science in Clinical Pharmacology and Drug Development for Improving Health Outcomes in Patients. Issue 4 (23rd March 2020) Authors: Peck, Richard W.; Shah, Pratik; Vamvakas, Spiros; van der Graaf, Piet H. Journal: Clinical pharmacology & therapeutics Issue: Volume 107:Issue 4(2020) Page Start: 683 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
5. How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory‐HTA parallel scientific advice. (1st July 2016) Authors: Tafuri, Giovanni; Pagnini, Margherita; Moseley, Jane; Massari, Marco; Petavy, Frank; Behring, Antje; Catalan, Arantxa; Gajraj, Elangovan; Hedberg, Niklas; Obach, Mercè; Osipenko, Leeza; Russo, Pierluigi; Van De Casteele, Marc; Zebedin, Eva‐Maria; Rasi, Guido; Vamvakas, Spiros Journal: British journal of clinical pharmacology Issue: Volume 82:Number 4(2016:Oct.) Page Start: 965 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
6. Marketing authorisation of orphan medicines in Europe from 2000 to 2013. Issue 2 (February 2018) Authors: Hofer, Matthias P.; Hedman, Hanna; Mavris, Maria; Koenig, Franz; Vetter, Thorsten; Posch, Martin; Vamvakas, Spiros; Regnstrom, Jan; Aarum, Stiina Journal: Drug discovery today Issue: Volume 23:Issue 2(2018) Page Start: 424 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
7. Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth. Issue 5 (12th November 2020) Authors: Eichler, Hans‐Georg; Pignatti, Francesco; Schwarzer‐Daum, Brigitte; Hidalgo‐Simon, Ana; Eichler, Irmgard; Arlett, Peter; Humphreys, Anthony; Vamvakas, Spiros; Brun, Nikolai; Rasi, Guido Journal: Clinical pharmacology & therapeutics Issue: Volume 109:Issue 5(2021) Page Start: 1212 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
8. Regulators' Advice Can Make a Difference: European Medicines Agency Approval of Zynteglo for Beta Thalassemia. Issue 3 (8th November 2019) Authors: Schuessler‐Lenz, Martina; Enzmann, Harald; Vamvakas, Spiros Journal: Clinical pharmacology & therapeutics Issue: Volume 107:Issue 3(2020) Page Start: 492 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
9. Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines. Issue 6 (24th April 2020) Authors: Moseley, Jane; Vamvakas, Spiros; Berntgen, Michael; Cave, Alison; Kurz, Xavier; Arlett, Peter; Acha, Virginia; Bennett, Simon; Cohet, Catherine; Corriol‐Rohou, Solange; Du Four, Emma; Lamoril, Christelle; Langeneckert, Anja; Koban, Maren; Pasté, Muriel; Sandler, Susan; Van Baelen, Karin; Cangini,... Journal: British journal of clinical pharmacology Issue: Volume 86:Issue 6(2020) Page Start: 1034 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
10. The impact of parallel regulatory–health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations. (5th March 2018) Authors: Tafuri, Giovanni; Lucas, Inês; Estevão, Steve; Moseley, Jane; d'Andon, Anne; Bruehl, Hannah; Gajraj, Elangovan; Garcia, Sonia; Hedberg, Niklas; Massari, Marco; Molina, Andrea; Obach, Mercè; Osipenko, Leeza; Petavy, Frank; Petschulies, Marco; Pontes, Caridad; Russo, Pierluigi; Schiel, Anja; Van de... Journal: British journal of clinical pharmacology Issue: Volume 84:Number 5(2018:Nov.) Page Start: 1013 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗