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LIB recommended reading - Head

Library: Recommended reading ...

We like to draw your attention to publications and reviews that address topics that are important in our field. This focuses on recent publications, but older ‘pearls’ are suggested as well. This is a continuous project that will be updated regularly, also based on your feedback, comments and suggestions.

Sit back and wonder ...

Schiltz M. Science Without Publication Paywalls: cOAlition S for the Realisation of Full and Immediate Open Access.
Neurosci., 04 September 2018 | https://doi.org/10.3389/fnins.2018.00656 {TXT}

Ramamoorthy A, Sadler BM, van Hasselt JGC, Elassaiss-Schaap J, Kasichayanula S, Edwards AY, van der Graaf PH, Zhang L, Wagner JA. Crowdsourced Asparagus Urinary Odor Population Kinetics. CPT Pharmacometrics Syst Pharmacol. 2018 Jan;7(1):34-41 {ABS | TXT}

Leonti M & Casu L. Ethnopharmacology of Love. Front. Pharmacol., 03 July 2018 | https://doi.org/10.3389/fphar.2018.00567 {TXT}

Labos C. It Ain’t Necessarily So: Why Much of the Medical Literature Is Wrong. Medscape 2014 {TXT}

Colquhoun D. An investigation of the false discovery rate and the misinterpretation of P values. R Soc Open Sci 2014;191:140216 {TXT}

BEING AWARE OF POORLY PREDICTABLE RISKS

Chaikin P. The Bial 10-2474 Phase 1 Study-A Drug Development Perspective and Recommendations for Future First-in-Human Trials. J Clin Pharmacol. 2017 Jun;57(6):690-703. {ABS | TXT}

Kaur R, Sidhu P, Singh S. What failed BIA 10-2474 Phase I clinical trial? Global speculations and recommendations for future Phase I trials. J Pharmacol Pharmacother. 2016 Jul-Sep;7(3):120-6. {TXT}

CT-Planning & -design

Fruhner K, Hartmann G, Sudhop T. Analysis of integrated clinical trial protocols in early phases of medicinal product development. Eur J Clin Pharmacol. 2017 Dec;73(12):1565-1577. {ABS | TXT}

van Gerven J, Cohen A. Integrating data from the Investigational Medicinal Product Dossier/investigator’s brochure. A new tool for translational integration of preclinical effects. Br J Clin Pharmacol. 2018 Jul;84(7):1457-1466. {TXT}

Calis KA, Archdeacon P, Bain R, DeMets D, Donohue M, Elzarrad MK, Forrest A, McEachern J, Pencina MJ, Perlmutter J, Lewis RJ. Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative. Clin Trials. 2017 Aug;14(4):342-348 {TXT}

Fleming TR, DeMets DL, Roe MT, Wittes J, Calis KA, Vora AN, Meisel A, Bain RP, Konstam MA, Pencina MJ, Gordon DJ, Mahaffey KW, Hennekens CH, Neaton JD, Pearson GD, Andersson TL, Pfeffer MA, Ellenberg SS. Data monitoring committees: Promoting best practices to address emerging challenges. Clin Trials. 2017 Apr;14(2):115-123 {TXT}.

Park JJ, Thorlund K, Mills EJ. Critical concepts in adaptive clinical trials. Clin Epidemiol. 2018 Mar 23;10:343-351. {TXT }

Thorlund K, Haggstrom J, Park JJ, Mills EJ. Key design considerations for adaptive clinical trials: a primer for clinicians. BMJ. 2018 Mar 8;360:k698. {TXT}

Methods in applied clinical pharmacology

Hermann R, Derendorf H, von Richter O, Rostami-Hodjegan A. Core Entrustable Professional Activities in Clinical Pharmacology: Pearls for Clinical Practice: Drug-Drug and Food-Drug Interactions. J Clin Pharmacol. 2018 Mar 7. doi: 10.1002/jcph.1088. [Epub ahead of print] {ABS}

Li M, Zhao P, Pan Y, Wagner C. Predictive Performance of Physiologically Based Pharmacokinetic Models for the Effect of Food on Oral Drug Absorption: Current Status. CPT Pharmacometrics Syst Pharmacol. 2018 Feb;7(2):82-89. {ABS | TXT}

Lin L, Wong H. Predicting Oral Drug Absorption: Mini Review on Physiologically-Based Pharmacokinetic Models. Pharmaceutics. 2017 Sep 26;9(4). pii: E41. {ABS | TXT}

Franconi F, Campesi I. Pharmacogenomics, pharmacokinetics and pharmacodynamics: interaction with biological differences between men and women. Br J Pharmacol. 2014 Feb; 171(3): 580–594. {ABS | TXT}

Methods in Bioequivalence

Chen ML, Blume H, Beuerle G, Davit B, Mehta M, Potthast H, Schug B, Tsang YC, Wedemeyer RS, Weitschies W, Welink J. The Global Bioequivalence Harmonization Initiative: Summary report for EUFEPS international conference. Eur J Pharm Sci. 2018 Jan 1;111:153-157. {ABS | TXT}

Muñoz J, Alcaide D, Ocaña J. Consumer’s risk in the EMA and FDA regulatory approaches for bioequivalence in highly variable drugs. Stat Med. 2016 May 30;35(12):1933-43. {ABS | TXT}

Shaik Mastan, Thirunagari Bhavya Latha, Sathe Ajay. The basic regulatory considerations and prospects for conducting bioavailability/bioequivalence (BA/BE) studies – an overview. Comparative Effectiveness Research 2011:1 1–25 {ABS | TXT}

Targets in drug development

Donnenberg VS, Mandic M, Rhee JC, Burns TF, Meibohm B, Korth-Bradley JM. Core Entrustable Professional Activities in Clinical Pharmacology for Entering Residency: Biologics. J Clin Pharmacol. 2017 Aug;57(8):947-955. {ABS | TXT}

Lok AS, Zoulim F, Dusheiko G, Ghany MG. Hepatitis B cure: From discovery to regulatory approval. J Hepatol. 2017 Oct;67(4):847-861. {ABS | TXT}