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Journal Clin Pharmacol Ther

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Tribute to Professor Hartmut Derendorf - 1953 to 2020: Driving force in Clinical Pharmacology and Mentor Extraordinaire.

Julie A Johnson, Stephan Schmidt,

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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Efficacy and safety of ticagrelor monotherapy in patients undergoing percutaneous coronary intervention: a meta-analysis.

Georg Gelbenegger, Christian Schoergenhofer, Bernd Jilma, Gloria M Gager, Al Medina Dizdarevic, Mamas A Mamas, Biljana Parapid, Poonam Velagapudi, Jolanta M Siller-Matula,

Dual antiplatelet therapy (DAPT) and subsequent P2Y12 inhibitor monotherapy, particularly ticagrelor, is an emerging treatment strategy in patients undergoing percutaneous coronary intervention (PCI). This meta-analysis was designed to investigate whether short-term DAPT followed by ticagrelor monotherapy is associated with a favorable outcome as compared to standard DAPT. 1-3 months of ... Read more >>

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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American Society for Clinical Pharmacology and Therapeutics.

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, 109 Suppl 1:S5-S88]

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COVID-19 and the Emerging Regulatory Guidance for Ongoing Clinical Trials in the European Union.

Amos Jochanan de Jong, Yared Santa-Ana-Tellez, Ghislaine José Madeleine Wilhelmien van Thiel, Mira Gerta Petra Zuidgeest, Satu Johanna Siiskonen, Dinesh Mistry, Anthonius de Boer, Helga Gardarsdottir, ,

The COVID-19 pandemic and the accompanying control measures have significantly affected clinical trial (CT) conduct and sponsors have needed to make rapid changes to their CT operations. As a result, regulatory guidance was pivotal during the initial phases of the pandemic. This study aimed to evaluate the regulatory readiness and ... Read more >>

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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Clinical design and analysis strategies for the development of gene therapies: considerations for quantitative drug development in the age of genetic medicine.

Avery McIntosh, Oleksandr Sverdlov, Li Yu, Petra Kaufmann,

Cell and gene therapies have shown enormous promise across a range of diseases in recent years. Numerous adoptive cell therapy modalities as well as systemic and direct-to-target tissue gene transfer administrations are currently in clinical development. The clinical trial design, development, reporting, and analysis of novel cell and gene therapies ... Read more >>

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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Systematic review and patient-level meta-analysis of SARS-CoV-2 viral dynamics to model response to antiviral therapies.

Silke Gastine, Juanita Pang, Florencia A T Boshier, Simon J Carter, Dagan O Lonsdale, Mario Cortina-Borja, Ivan F N Hung, Judy Breuer, Frank Kloprogge, Joseph F Standing,

SARS-CoV-2 viral loads change rapidly following symptom onset so to assess antivirals it is important to understand the natural history and patient factors influencing this. We undertook an individual patient-level meta-analysis of SARS-CoV-2 viral dynamics in humans to describe viral dynamics and estimate the effects of antivirals used to-date. This ... Read more >>

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs.

Sumathi Nambiar, Sarah Walinsky, Katherine Schumann,

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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The Pharmacological War Against and With Opioids.

Piet H van der Graaf,

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, 109(3):557-559]

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Response similarity assessment between polyarticular juvenile idiopathic arthritis and adult rheumatoid arthritis for biologics.

Renu Singh, Vijay D Ivaturi, Justin Penzenstadler, Tao Liu, Jianmeng Chen, Anshu Marathe, Ping Ji, Rachel Glaser, Nikolay Nikolov, Chandrahas Sahajwalla,

Poly-articular juvenile idiopathic arthritis (pJIA) is a pediatric chronic inflammatory arthritis, much like rheumatoid arthritis (RA) in adults. Drug development for pJIA can potentially be expedited by using extrapolation of efficacy from adult RA, however the lack of understanding of response and exposure relationship between pJIA and RA to therapeutic ... Read more >>

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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Mycophenolic acid exposure prediction using machine learning.

Jean-Baptiste Woillard, Marc Labriffe, Jean Debord, Pierre Marquet,

Therapeutic drug monitoring of mycophenolic acid (MPA) based on area under the curve (AUC) is well established and machine learning (ML) approaches could help to estimate AUC. The aim of this work is to estimate the AUC of MPA in organ transplant patients using Xgboost ML models. A total of ... Read more >>

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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NT-proBNP qualifies as a surrogate for clinical endpoints in heart failure.

Walter Schmitt, Hauke Rühs, Rolf Burghaus, Christian Diedrich, Sulav Duwal, Thomas Eissing, Dirk Garmann, Michaela Meyer, Bart Ploeger, Jörg Lippert,

N-terminal pro b-type natriuretic peptide (NT-proBNP) is a well-established biomarker in heart failure (HF) but controversially discussed as a potential surrogate marker in HF trials. We analyzed the NT-proBNP/mortality relationship in real world data (RWD) of 108,330 HF patients from the IBM Watson Health<sup>TM</sup> Explorys® database and compared it with ... Read more >>

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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Physiologically based pharmacokinetic modelling to support the clinical management of drug-drug interactions with bictegravir.

Felix Stader, Manuel Battegay, Catia Marzolini,

Bictegravir is equally metabolized by cytochrome P-450 (CYP)3A and uridine diphosphate-glucuronosyltransferase (UGT)1A1. Drug-drug interaction (DDI) studies were only conducted for strong inhibitors and inducers, leading to some uncertainty whether moderate perpetrators or multiple drug associations, can be safely co-administered with bictegravir. We used physiologically based pharmacokinetic (PBPK) modelling to simulate ... Read more >>

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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Moving from Point-based Analysis to Systems-based modeling: Integration of Knowledge to Address Antimicrobial Resistance against MDR Bacteria.

Estefany Garcia, Neang Ly, John K Diep, Gauri G Rao,

The emerging discipline of Quantitative Systems Pharmacology (QSP) enables the integration of quantitative experimental data describing the interactions between the various biological processes within the system using mathematical modeling to gain better insights into the factors that drive disease pathogenicity and influence antibiotic pharmacokinetics (PK)/pharmacodynamics (PD). Through our perspective we ... Read more >>

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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Impact of Multiple Prescriptions with Anticholinergic Properties on Adverse Clinical Outcomes in the Elderly: a Longitudinal Cohort Study in Taiwan.

Wen-Han Hsu, Shih-Tsung Huang, Wan-Hsuan Lu, Yu-Wen Wen, Liang-Kung Chen, Fei-Yuan Hsiao,

The cumulative effect of multiple pharmaceutics with anticholinergic properties, i.e., anticholinergic burden, can serve as an indicator of suboptimal prescribing in the elderly. Yet, no research is available concerning the effect of different compositions of score on adverse outcomes under the same anticholinergic burden. This population-based cohort study investigated whether ... Read more >>

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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Sustained inhibition of calcineurin activity with a Melt-Dose Once-daily Tacrolimus formulation in renal transplant recipients.

Pere Fontova, Helena Colom, Raül Rigo-Bonnin, Oriol Bestard, Anna Vidal-Alabró, Lisanne Van Merendonk, Gema Cerezo, Carolina Polo Techn, Nuria Montero, Edoardo Melilli, Anna Manonelles, Maria Meneghini, Ana Coloma, Josep M Cruzado, Joan Torras, Josep M Grinyó, Nuria Lloberas,

Tacrolimus (Tac) is the cornerstone calcineurin inhibitor in transplantation. Extended-release Meltdose formulation (Tac-LCP) offers better bioavailability compared to immediate-release formulation (Tac-IR). We postulated that the less fluctuating pharmacokinetic profile of Tac-LCP might maintain a sustained inhibition of calcineurin activity (CNA) between dose intervals. Higher concentrations (C<sub>max</sub> ) after Tac-IR may ... Read more >>

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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Assuring Access to Safe Medicines in Pregnancy and Breastfeeding.

Janet Nooney, Shannon Thor, Corinne de Vries, John Clements, Leyla Sahin, Wei Hua, Darcie Everett, Cosimo Zaccaria, Robert Ball, Agnes Saint-Raymond, Lynne Yao, June Raine, Sandra Kweder,

Scientists and regulators in Europe and the United States (U.S.) continue to seek methods and strategies to improve knowledge on rational use of medicines for pregnant and breastfeeding populations, an important subset of women's health. Regulatory agencies have made strides toward improvement, but much more is needed. Recognising the importance ... Read more >>

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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Defining Clinically-Relevant Target Populations Using Real-World Data to Guide the Design of Representative Antidiabetic Drug Trials.

Richeek Pradhan, Devin Abrahami, Hui Yin, Oriana H Y Yu, Vaishali Sahasrabudhe, Elodie Baumfeld Andre, Laurent Azoulay,

The United States Food and Drug Administration is considering replacing cardiovascular outcome trials (CVOTs) of antidiabetic drugs with trials that better represent patients with type 2 diabetes. However, designing such representative trials requires understanding the underlying target populations (i.e., populations intended to receive the drug in the real-world setting). Thus, ... Read more >>

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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Reapproaching old treatments: considerations for PK/PD studies on phage therapy for bacterial respiratory infections.

Alan A Schmalstig, Soha Freidy, Patrick O Hanafin, Miriam Braunstein, Gauri G Rao,

Antibiotic resistant bacterial respiratory infections are a significant global health burden, and new therapeutic strategies are needed to control the problem. For bacterial respiratory infections, this need is emphasized by the rise in antibiotic resistance and a lean drug development pipeline. Bacteriophage (phage) therapy is a promising alternative to antibiotics. ... Read more >>

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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Key challenges in providing effective antibiotic therapy for critically ill patients with bacterial sepsis and septic shock.

Cornelia B Landersdorfer, Roger L Nation,

Early initiation of effective antibiotic therapy is vitally important for saving the lives of critically ill patients with sepsis or septic shock. The susceptibility of the infecting pathogen and the ability of the selected dosage regimen to safely achieve the required antibiotic exposure need to be carefully considered to achieve ... Read more >>

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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From Therapeutic Drug Monitoring to Model-Informed Precision Dosing for Antibiotics.

Sebastian G Wicha, Anne-Grete Märtson, Elisabet I Nielsen, Birgit C P Koch, Lena E Friberg, Jan-Willem Alffenaar, Iris K Minichmayr, ,

Therapeutic drug monitoring (TDM) and model-informed precision dosing (MIPD) have evolved as important tools to inform rational dosing of antibiotics in individual patients with infections. In particular, critically ill patients display altered, highly variable pharmacokinetics and often suffer from infections caused by less susceptible bacteria. Consequently, TDM has been used ... Read more >>

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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Minireview: Antimicrobial Dose Selection under the Animal Rule.

Kunyi Wu, Su-Young Choi, Kimberly Bergman, Shirley Seo,

The Food and Drug Administration's (FDA's) ''Animal Rule'' provides a unique regulatory pathway for drugs and biologics intended to treat serious or life-threatening conditions caused by exposure to lethal or permanently disabling chemical, biological, radiological or nuclear agents when human efficacy studies are not ethical and field trials are not ... Read more >>

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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Combating multidrug-resistant bacteria by integrating a novel target site penetration and receptor binding assay platform into translational modeling.

Yinzhi Lang, Nirav R Shah, Xun Tao, Stephanie M Reeve, Jieqiang Zhou, Bartolome Moya, Alaa R M Sayed, Suresh Dharuman, Jeremiah L Oyer, Alicja J Copik, Brett A Fleischer, Eunjeong Shin, Carolin Werkman, Kari B Basso, Deanna Deveson Lucas, Dhruvitkumar S Sutaria, Marianne Megroz, Tae Hwan Kim, Victoria Loudon-Hossler, Amy Wright, Rossie H Jimenez-Nieves, Miranda J Wallace, Keisha C Cadet, Yuanyuan Jiao, John D Boyce, Eric D LoVullo, Herbert P Schweizer, Robert A Bonomo, Nagakumar Bharatham, Brian T Tsuji, Cornelia B Landersdorfer, Michael H Norris, Beom Soo Shin, Arnold Louie, Venkataraman Balasubramanian, Richard E Lee, George L Drusano, Jürgen B Bulitta,

Multidrug-resistant bacteria are causing a serious global health crisis. A dramatic decline in antibiotic discovery and development investment by pharmaceutical industry over the last decades has slowed the adoption of new technologies. It is imperative that we create new mechanistic insights based on latest technologies, and employ translational strategies to ... Read more >>

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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Tribute: Sir Colin Terence Dollery, MB, Ch, MD (Hon).

Arthur J Atkinson,

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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Biomarker-Guided Individualization of Antibiotic Therapy.

Linda B S Aulin, Dylan W de Lange, Mohammed A A Saleh, Piet H van der Graaf, Swantje Völler, J G Coen van Hasselt,

Treatment failure of antibiotic therapy due to insufficient efficacy or occurrence of toxicity is a major clinical challenge, and is expected to become even more urgent with the global rise of antibiotic resistance. Strategies to optimize treatment in individual patients are therefore of crucial importance. Currently, therapeutic drug monitoring plays ... Read more >>

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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Population-based signals of antidepressant drug interactions associated with unintentional traumatic injury.

Charles E Leonard, Colleen M Brensinger, Emily K Acton, Todd A Miano, Ghadeer K Dawwas, John R Horn, Sophie Chung, Warren B Bilker, Sascha Dublin, Samantha E Soprano, Thanh Phuong Pham Nguyen, Melanie M Manis, David W Oslin, Douglas J Wiebe, Sean Hennessy,

Antidepressants are very widely used and associated with traumatic injury, yet little is known about their potential for harmful drug interactions. We aimed to identify potential drug interaction signals by assessing concomitant medications (precipitant drugs) taken with individual antidepressants (object drugs) that were associated with unintentional traumatic injury. We conducted ... Read more >>

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2021, :]

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