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}

COVID-10 Clinical Pharmacology

General Reviews

Becker RC. Covid-19 treatment update: follow the scientific evidence. J Thromb Thrombolysis. 2020 Apr 27:1-11. {TXT}

Şimşek Yavuz S, Ünal S. Antiviral treatment of COVID-19. Turk J Med Sci. 2020 Apr 21;50(SI-1):611-619 {TXT}

Sanders JM, Monogue ML, Jodlowski TZ, Cutrell JB. Pharmacologic Treatments for Coronavirus Disease 2019 (COVID-19): A Review. JAMA. 2020 Apr 13. doi: 10.1001 {TXT}


Trial Methodology

Glasziou PP, Sanders S, Hoffmann T. Waste in COVID-19 research. BMJ. 2020 May 12;369:m1847. doi: 10.1136.

Jin X, Pang B, Zhang J, Liu Q, et al. Core Outcome Set for Clinical Trials on Coronavirus Disease 2019 (COS-COVID). Engineering (Beijing). 2020 Mar 18. doi: 10.1016/j.eng.2020.03.002.  {TXT}


Chloroquine and Hdroxychloroquine

Mehra M et al. Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis. The Lancet 2020; DOI: https://doi.org/10.1016/S0140-6736(20)31180-6 {TXT}

Funck-Brentano C, Salem JE. Chloroquine or hydroxychloroquine for COVID-19: why might they be hazardous? The Lancet 2020; DOI: https://doi.org/10.1016/S0140-6736(20)31180-6 {TXT}

Gao J, Hu S. Update on the use of chloroquine/hydroxychloroquine to treat coronavirus disease 2019 (COVID-19). Biosci Trends. 2020 Apr 13. doi: 10.5582 {TXT}

Singh AK, Singh A, Shaikh A, Singh R, Misra A. Chloroquine and hydroxychloroquine in the treatment of COVID-19 with or without diabetes: A systematic search and a narrative review with a special reference to India and other developing countries. Diabetes Metab Syndr. 2020 May-Jun;14(3):241-246 {TXT}

Sahraei Z, Shabani M, Shokouhi S, Saffaei A. Aminoquinolines against coronavirus disease 2019 (COVID-19): chloroquine or hydroxychloroquine. Int J Antimicrob Agents. 2020 Apr;55(4):105945. doi: 10.1016 {TXT}

Pastick KA, Okafor EC, Wang F, Lofgren SM, Skipper CP, Nicol MR, Pullen MF, Rajasingham R, McDonald EG, Lee TC, Schwartz IS, Kelly LE, Lother SA, Mitjà O, Letang E, Abassi M, Boulware DR. Review: Hydroxychloroquine and Chloroquine for Treatment of SARS-CoV-2 (COVID-19). Open Forum Infect Dis. 2020 Apr 15;7(4):ofaa130. doi: 10.1093 {TXT}

Saqrane S, El Mhammedi MA. Review on the global epidemiological situation and the efficacy of chloroquine and hydroxychloroquine for the treatment of COVID-19. New Microbes New Infect. 2020 Apr 14;35:100680. doi: 10.1016 {TXT}

{ACPS-CdM: 28.May.2020}

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

Gomeni R, Fang LL, Bressolle-Gomeni F, Spencer TJ, Faraone SV, Babiskin A. A general framework for assessing IVIVC as a tool for maximizing the benefit-risk ratio of a treatment using a convolution-based modeling approach. CPT Pharmacometrics Syst Pharmacol. 2019 Jan 18. doi: 10.1002/psp4.12378 {TXT}

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}

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}

Chu X, Liao M, Shen H, Yoshida K, Zur AA, Arya V, Galetin A, Giacomini KM, Hanna I, Kusuhara H, Lai Y, Rodrigues D, Sugiyama Y, Zamek-Gliszczynski MJ, Zhang L; International Transporter Consortium. Clinical Probes and Endogenous Biomarkers as Substrates for Transporter Drug-Drug Interaction Evaluation: Perspectives From the International Transporter Consortium. Clin Pharmacol Ther. 2018 Nov;104(5):836-864. doi: 10.1002/cpt.1216 {ABS}

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}