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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 ...

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

CT-Management & GCP-compliance

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

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.
ABS | TXT

CT-Planning & -design

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}
leming 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]
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

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