Expert Review of Clinical Pharmacology




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Dostarlimab for the treatment of advanced endometrial cancer

Andres Redondo, Alejandro Gallego & Marta Mendiola

doi : 10.1080/17512433.2022.2044791

Volume 15, Issue 1, Pages 1-9

Between 20% and 30% of the endometrial cancers (EC) are associated with a deficiency of a mismatch repair (MMRd) protein or high microsatellite instability (MSI-H), characteristics that render the tumor more sensitive to immune checkpoint inhibitors. There is no standard treatment for advanced EC after progression to a platinum-containing regimen.

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WHO collaborative registration procedure using stringent regulatory authorities’ medicine evaluation: reliance in action?

Alexandra Vaz, Mariana Roldão Santos, Luther Gwaza, Elena Mezquita González, Magdalena Pajewska Lewandowska, Samvel Azatyan & Agnès Saint-Raymond

doi : 10.1080/17512433.2022.2037419

Volume 15, Issue 1, Pages 11-17

The regulatory approval of medical products in countries with limited regulatory resources can be lengthy, which often compromises patients’ timely access to much-needed medicines. To improve the efficiency of regulatory systems, reliance is being used. Reliance allows an authority to leverage the work performed by other authorities, such as scientific evaluations, to decide on medical products approval within their jurisdiction. This reduces duplication of regulatory efforts, resources and time, while maintaining national sovereignty.

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The era of lenalidomide maintenance therapy in multiple myeloma: settings for achieving best outcomes

Meghana Kesireddy & Sarah A. Holstein

doi : 10.1080/17512433.2022.2032656

Volume 15, Issue 1, Pages 19-31

For patients with multiple myeloma who are eligible for high-dose melphalan therapy and autologous stem cell transplant (ASCT), the strategy of maintenance with low-dose lenalidomide therapy has become the current standard of care. However, this strategy is not curative, and many unanswered questions remain regarding the optimization of lenalidomide-based maintenance therapy.

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Angiotensin converting enzyme and angiotensin converting enzyme inhibitors in dermatology: a narrative review

Yang Lo & Tsen-Fang Tsai

doi : 10.1080/17512433.2022.2045950

Volume 15, Issue 1, Pages 33-42

Angiotensin converting enzyme inhibitors (ACEI) are commonly used for cardiovascular diseases. The evidence supporting the use of ACEI in dermatology is limited.

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Intraperitoneal therapy for gastric cancer peritoneal carcinomatosis

Kazuto Harada, Kohei Yamashita, Masaaki Iwatsuki, Hideo Baba & Jaffer A. Ajani

doi : 10.1080/17512433.2022.2044790

Volume 15, Issue 1, Pages 43-49

Gastric adenocarcinoma (GAC) is one of the most aggressive malignancies worldwide and has a poor prognosis. Multidisciplinary therapies are used in its treatment, but the prognosis for GAC patients with peritoneal metastases (PM) remains poor and there is no effective established approach.

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The pharmacotherapeutics of sarcoidosis

Patrick Mangialardi, Richart Harper & Timothy E Albertson

doi : 10.1080/17512433.2022.2032657

Volume 15, Issue 1, Pages 51-64

Sarcoidosis is a multi-system, inflammatory, and granulomatous disease that can damage multiple organs. Several drugs have been used to treat sarcoidosis, but few have randomized-controlled trials (RCTs) to understand their efficacy. This lack of RCTs and the heterogenous nature of sarcoidosis makes for a challenge to the provider caring for these patients.

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Association between myocarditis and antipsychotics other than clozapine: a systematic literature review and a pharmacovigilance study using VigiBase

Carlos De Las Cuevas, Emilio J. Sanz, Christopher Rohde & Jose de Leon

doi : 10.1080/17512433.2022.2032659

Volume 15, Issue 1, Pages 65-78

Pharmacovigilance studies have definitely established that clozapine can cause myocarditis. Two published reviews suggested that on rare occasions other antipsychotics may induce myocarditis.

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Proton pump inhibitors may reduce the risk of high-grade dysplasia and/or esophageal adenocarcinoma in Barrett’s esophagus: a systematic review and meta-analysis

Haijuan Yao, Le Wang, Hongyu Li, Shixue Xu, Zhaohui Bai, Yanyan Wu, Hongxin Chen, Hemant Goyal & Xingshun Qi

doi : 10.1080/17512433.2022.2008909

Volume 15, Issue 1, Pages 79-88

Barrett’s esophagus (BE) is an important risk factor for high-grade dysplasia (HGD) and/or esophageal adenocarcinoma (EAC). The effect of proton pump inhibitors (PPIs) on the chemoprevention of HGD and/or EAC arising from BE remains controversial.

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The effect of vitamin D supplementation on glycemic status of elderly people with prediabetes: a 12-month open-label, randomized-controlled study

Evangelia Zaromytidou, Theocharis Koufakis, Georgios Dimakopoulos, Despina Drivakou, Stavroula Konstantinidou, Vasiliki Antonopoulou, Maria Grammatiki, Eleni Manthou, Ioannis Iakovou, Anna Gotzamani-Psarrakou & Kalliopi Kotsa

doi : 10.1080/17512433.2022.2043153

Volume 15, Issue 1, Pages 89-97

Data on the efficacy of vitamin D in improving the glycemic status of elderly people with prediabetes are scarce. This open-label, randomized-controlled trial investigated the effect of vitamin D supplementation on glycemic markers of Greek people with prediabetes aged 60 years or above, over 12 months.

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Pharmacogenetics-based population pharmacokinetic analysis for dose optimization of ritonavir-boosted atazanavir in Thai adult HIV-infected patients

Noppaket Singkham, Anchalee Avihingsanon, Richard C Brundage, Angela K Birnbaum, Narukjaporn Thammajaruk, Kiat Ruxrungtham, Torsak Bunupuradah, Sasisopin Kiertiburanakul, Ploenchan Chetchotisakd, Baralee Punyawudho & LASA study team

doi : 10.1080/17512433.2022.2000858

Volume 15, Issue 1, Pages 99-108

This population pharmacokinetic–pharmacogenetic study aimed to investigate the optimal dose of RTV-boosted ATV (ATV/RTV) for Thai adult HIV-infected patients.

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Comparison of the registration process of the medicines control authority of Zimbabwe with Australia, Canada, Singapore, and Switzerland: benchmarking best practices

Tariro Sithole, Sam Salek, Gugu Mahlangu & Stuart Walker

doi : 10.1080/17512433.2022.1987883

Volume 15, Issue 1, Pages 109-119

Benchmarking regulatory systems of low- and middle-income countries with mature systems provides an opportunity to identify gaps, enhance review quality, and reduce registration timelines, thereby improving patients’ access to medicines. The aim of this study was to compare the medicines registration process of the Medicines Control Authority of Zimbabwe (MCAZ) with the regulatory processes in Australia, Canada, Singapore, and Switzerland.

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