Drug Approvals Research

06:57 EST 20th February 2018 | BioPortfolio

Application of physiologically based pharmacokinetic modeling to the prediction of drug-drug and drug-disease interactions for rivaroxaban.

Rivaroxaban is a direct oral anticoagulant with a large inter-individual variability. The present study is to develop a physiologically based pharmacokinetic (PBPK) model to predict several scenarios in clinical practice.

Drug approval based on randomized phase 3 trials for relapsed malignancy: analysis of oncologic drugs granted accelerated approval, publications and clinical trial databases.

Background As relapsed disease is frequently the first target of newly developed therapies, it is vital to address the difficulty in demonstrating the efficacy of new drugs for relapsed malignancy in randomized phase 3 trials. Methods We analyzed the approved indications, target populations, and development status of post-marketing confirmatory trials of all oncology-related drugs that were grante...

Netarsudil Ophthalmic Solution 0.02%: First Global Approval.

Netarsudil ophthalmic solution 0.02% (hereafter referred to as netarsudil 0.02%) [Rhopressa] is a Rho-associated protein kinase inhibitor that is thought to lower intraocular pressure (IOP) by increasing aqueous humour outflow through the trabecular meshwork. It has been developed by Aerie Pharmaceuticals and was recently approved in the USA for the reduction of elevated IOP in patients with open-...

A headspace-gas chromatography method for isopropanol determination in warfarin sodium products as a measure of drug crystallinity.

Coumadin® a nd s everal generic products of warfarin s odium (WS) contain the crystalline form (clathrate) in which WS and isopropanol (IPA) are associated in a 2:1 molar ratio. IPA is critical in maintaining the WS crystalline structure. Physicochemical properties of the drug and drug product may change when the crystalline drug transforms to amorphous form. A headspace-gas chromatography (HS-GC...

Improving sustained drug delivery from ophthalmic lens materials through the control of temperature and time of loading.

Although the possibility of using drug-loaded ophthalmic lens to promote sustained drug release has been thoroughly pursued, there are still problems to be solved associated to the different alternatives. In this work, we went back to the traditional method of drug loading by soaking in the drug solution and tried to optimize the release profiles by changing the temperature and the time of loading...

Evaluation of cAMS forC microtracer ADME studies: opportunities to change the current drug development paradigm.

Although regulatory guidances require human metabolism information of drug candidates early in the development process, the human mass balance study (or hADME study), is performed relatively late. hADME studies typically involve the administration of aC-radiolabelled drug where biological samples are measured by conventional scintillation counting analysis. Another approach is the administration o...

Advancements in drug development for diarrhea-predominant irritable bowel syndrome.

Introduction Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common disorder characterized by a complex pathophysiology hampering optimal targeted drug development. Recent advances in our understanding of key underlying mechanisms prompted novel therapeutics including novel pharmacological approaches. Areas covered This review summarizes the latest advancements in the pipeline of IBS-D ...

Active Brazilian crack cocaine users: nutritional, anthropometric, and drug use profiles.

To evaluate the nutritional status of crack users and to analyze its correlation with drug use profiles.

Increase of 10% in the Rate of Adverse Drug Reactions for Each Drug Administered in Hospitalized Patients.

To assess the risk factors, incidence and severity of adverse drug reactions in in-patients.

Verification of a physiologically-based pharmacokinetic model of ritonavir to estimate drug-drug interaction potential of CYP3A4 substrates.

Ritonavir is one of several ketoconazole alternatives used to evaluate strong CYP3A4 inhibition potential in clinical drug-drug interaction (DDI) studies. In this study, four physiologically-based pharmacokinetic (PBPK) models of ritonavir as an in vivo time-dependent inhibitor of CYP3A4 were created and verified for the oral doses of 20, 50, 100 and 200 mg using fraction absorbed (Fa) and oral cl...

Using in Vitro Evolution and Whole Genome Analysis (IVIEWGA) to discover next generation targets for antimalarial drug discovery.

Although many new anti-infectives have been discovered and developed solely using phenotypic cellular screening and assay optimization, most researchers recognize that structure-guided drug design is more practical and less costly. In addition, a greater chemical space can be interrogated with structure-guided drug design. The practicality of structure-guided drug design has launched a search for ...

Bioavailability Study of Niosomal Salbutamol Sulfate in Metered Dose Inhaler: Controlled Pulmonary Drug Delivery.

Poly(lactic-co-glycolic) Acid as a Slow-Release Drug-Carrying Matrix for Methotrexate Coated onto Intraocular Lenses to Conquer Posterior Capsule Opacification.

Posterior capsule opacification (PCO) still represents the main long-term complication of cataract surgery. Research into pharmacologic PCO prophylaxis is extensive. One promising candidate drug is methotrexate (MTX). Our aim is to determine the in vitro feasibility of MTX-loaded poly(lactic-co-glycolic) (PLGA) biomatrices sprayed on intraocular lenses (IOLs) as a drug-delivery implant.


Lesihmaniasis is one of the major neglected tropical disease caused by the parasite of the genus Leishmania. The disease has more than one clinical forms and the visceral form is considered fatal. With the lack of potential vaccine, chemotherapy is the major treatment source considered for the control of the disease in the infected people. Drugs including amphotericin B and miltefosine are widely ...

pH-sensitive doxorubicin-conjugated prodrug micelles with charge-conversion for cancer therapy.

Intelligent drug delivery systems with prolonged circulation time, reduced drug leakage in blood, target site-triggered drug release and endosomal escape are attractive and ideal for malignant tumor therapy. Herein, doxorubicin (DOX)-conjugated smart polymeric micelles based on 4-carboxy benzaldehyde-grafted poly (L-lysine)-block-poly (methacryloyloxyethyl phosphorylcholine) (PLL(CB/DOX)-b-PMPC) c...

Molecular epidemiology and drug sensitivity pattern of Mycobacterium tuberculosis strains isolated from pulmonary tuberculosis patients in and around Ambo Town, Central Ethiopia.

Tuberculosis (TB) is caused by M. tuberculosis complex and remains a major global public health problem. The epidemic remains a threat to sub-Saharan Africa, including Ethiopia, with further emergence of drug resistant TB. We investigated the drug sensitivity pattern and molecular epidemiology of mycobacterial strains isolated from pulmonary TB patients in and around Ambo town in Oromia Region, Ce...

Pityriasis lichenoides-like drug reaction: A clinical histopathologic study of 10 cases.

Lymphomatoid drug reactions can mimic endogenous T and B cell lymphoproliferative diseases.

Comparison of drug-eluting stents and drug-coated balloon for the treatment of drug-eluting coronary stent restenosis: A randomized RESTORE trial.

This study sought to evaluate the optimal treatment for in-stent restenosis (ISR) of drug-eluting stents (DESs).

Biocompatible and biodegradable zeolitic imidazolate framework/polydopamine nanocarriers for dual stimulus triggered tumor thermo-chemotherapy.

Zeolitic imidazolate frameworks (ZIFs) have attracted great interest as pH-sensitive drug carrier because of high drug loading and intrinsic biodegradability. In this work, a biocompatible NIR and pH-responsive drug delivery nanoplatform based on ZIFs (PDA-PCM@ZIF-8/DOX) is synthesized for in vivo cancer therapy. The biocompatibility of ZIFs is greatly improved by polydopamine (PDA) modifying and...

Corrigendum to "Marijuana and tobacco co-use among a nationally representative sample of US pregnant and non-pregnant women: 2005-2014 National Survey on Drug Use and Health findings" Drug Alcohol Depend. 177 (2017) 130-135.

Book Review: Introduction to Drug Disposition and Pharmacokinetics Curry Stephen H. Whelpton Robin . Introduction to Drug Disposition and Pharmacokinetics . New York : John Wiley , 2017 . $50 paperback/eBook. ISBN: 978-1-110-26104-9 .

Shot-noise-limited Doppler-broadened noise-immune cavity-enhanced optical heterodyne molecular spectrometry.

Shot-noise-limited Doppler-broadened (Db) noise-immune cavity-enhanced optical heterodyne molecular spectrometry (NICE-OHMS) has been realized by implementation of balanced detection. A characterization of the system based on Allan-Werle plots of the absorption coefficient, retrieved by fitting a model function to data, shows that the system has a white noise equivalent absorption per unit length ...

Drug survival and post-drug survival of first-line immunosuppressive treatments for atopic dermatitis: comparison between methotrexate and cyclosporine.

Cyclosporine and methotrexate are the two preferred first-line immunosuppressive treatments in atopic dermatitis. The aim of this study was to compare the treatment profiles of methotrexate and cyclosporine in daily practice as the first-line immunosuppressive treatment in atopic dermatitis, using two survival analyses, "drug survival" (time on the drug) and "post-drug survival" (time between two ...

Artificial intelligence in drug combination therapy.

Currently, the development of medicines for complex diseases requires the development of combination drug therapies. It is necessary because in many cases, one drug cannot target all necessary points of intervention. For example, in cancer therapy, a physician often meets a patient having a genomic profile including more than five molecular aberrations. Drug combination therapy has been an area of...

Advancing Pediatric Antibacterial Drug Development: A Critical Need to Reinvent our Approach.

The Clinical Trials Transformation Initiative convened with several groups in the pediatric antibacterial drug development community with the goal of identifying challenges and recommending ways to improve current practice. Attention to 5 major areas hold the promise of making new antibiotics available for use in children as soon as possible after they are approved for use in adults.

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