A5044607777- Statistical Methods in Clinical Trials
- Health Systems, Economic Evaluations, Quality of Life
- Advanced Causal Inference Techniques
- Neutropenia and Cancer Infections
- Blood disorders and treatments
- Biosimilars and Bioanalytical Methods
- Fibromyalgia and Chronic Fatigue Syndrome Research
- Treatment of Major Depression
- Restless Legs Syndrome Research
- Psychosomatic Disorders and Their Treatments
- Neurological disorders and treatments
- Parkinson's Disease Mechanisms and Treatments
- Pharmaceutical Economics and Policy
- Schizophrenia research and treatment
- Statistical Methods and Inference
- Diet and metabolism studies
- Meta-analysis and systematic reviews
- Rheumatoid Arthritis Research and Therapies
- Bacterial Identification and Susceptibility Testing
- Antibiotics Pharmacokinetics and Efficacy
- Epilepsy research and treatment
- Biomedical Ethics and Regulation
- Bipolar Disorder and Treatment
- Neuroblastoma Research and Treatments
- Hematopoietic Stem Cell Transplantation
ETH Zurich
2023-2025
Novartis (Switzerland)
2016-2024
Hexal (Germany)
2015-2016
Russian Cancer Research Center NN Blokhin
2016
Ludwig-Maximilians-Universität München
2016
Oncological Dispensary No. 2
2016
North-Western State Medical University named after I.I. Mechnikov
2016
Duke Medical Center
2016
UCB Pharma (Belgium)
2015
UCB Pharma (Germany)
2013-2015
Biosimilars of filgrastim are in widespread clinical use Europe. This phase III study compares biosimilar (EP2006), with the US-licensed reference product, Neupogen(®), breast cancer patients receiving (neo)adjuvant myelosuppressive chemotherapy (TAC).A total 218 5 µg/kg/day over six cycles were randomized 1:1:1:1 into four arms. Two arms received only one product (nonalternating), or reference, and two (alternating) alternating treatments during each cycle (biosimilar then vice versa). The...
Non-motor symptoms (NMS) of Parkinson's disease (PD) have a major impact on health-related quality life. This is the first randomized controlled trial to use NMS Scale (NMSS) as primary outcome assess treatment effects in PD.In this double-blind (NCT01300819), patients with PD and total NMSS score ≥40 were (2:1) rotigotine or placebo, titrated over 1-7 weeks optimal dose (≤8 mg/24 h for not receiving levodopa, ≤16 levodopa), maintained 12 weeks. The was change from baseline end maintenance....
Biosimilars provide safety, purity, and potency similar to those of a reference biologic product. An array protein analytical techniques was used compare the physicochemical properties proposed biosimilar filgrastim (EP2006), US-approved originator filgrastim, EU-approved filgrastim. Biological characterization involved surface plasmon resonance spectroscopy analyses in vitro proliferation assays. A randomized, double-blind, two-way crossover, phase I study healthy volunteers assessed...
Abstract Background. Pegfilgrastim is widely used for the prevention of chemotherapy-induced neutropenia. In highly regulated markets, there are currently no approved biosimilars pegfilgrastim. Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2) was a confirmatory efficacy and safety study designed compare proposed biosimilar LA-EP2006 with reference pegfilgrastim (Neulasta, Amgen) in early-stage breast cancer patients receiving adjuvant or neoadjuvant...
The pharmaceutical industry is increasingly shifting to decentralized clinical trials (DCTs) conducted at the patient's home, sometimes including trial material home delivery. traditional (CT) investigational site. Research suggests that centralized and have a large carbon footprint, with DCTs potentially providing patient-centric solutions. However, leaders must determine how integrate environmental, economic, social sustainability pillars into their portfolios subsequent downstream...
The aim of this 6-month observational study was to examine which clinical, eating- and lifestyle-related factors were associated with weight gain in patients initiating or switching oral olanzapine for the treatment schizophrenia bipolar mania. A total 622 outpatients four countries (China, Mexico, Romania, Taiwan) assessed at monthly intervals up 6 months. Mixed model repeated-measures analysis, adjusted baseline weight, used identify during therapy. After months therapy, LS mean change...
This randomized, double-blind trial compared proposed biosimilar LA-EP2006 with reference pegfilgrastim in women receiving chemotherapy for breast cancer (PROTECT-1).Women (≥18 years) were randomized to receive (n = 159) or 157) (Neulasta(®), Amgen) ≤6 cycles of (neo)-adjuvant TAC chemotherapy. Primary end point was duration severe neutropenia (DSN) during cycle 1 (number consecutive days absolute neutrophil count <0.5 × 10(9)/l) equivalence confirmed if 90% and 95% CIs within a ±1 day...
Aims: Reports from non-Asian populations indicate that painful physical symptoms (PPS) are associated with poorer clinical and functional outcomes in major depressive disorder (MDD). The purpose of this study is to report comparative changes disease severity, treatment patterns quality life observed East Asian patients MDD, without PPS, as assessed prospectively over a 3-month observation period. Methods: This observational enrolled 909 MDD psychiatric care settings China, Hong Kong, Korea,...
Biosimilar granulocyte-colony-stimulating factors (G-CSFs) have been available in the European Union since 2008, and Sandoz' biosimilar filgrastim was approved United States March 2015 for all of reference product's indications except acute radiation syndrome. G-CSFs largely embraced by medical community, some reservations about healthy-donor stem cell mobilization, which use outside clinical studies cautioned against members scientific community.In a two-center safety surveillance study...
Achieving optimal symptom control with minimal side effects is a major goal in clinical practice. Dual-agent dopamine receptor agonist (DA) therapy Parkinson's disease (PD) may represent promising approach to treatment, as the combination of different pharmacokinetic/pharmacological profiles result lesser need for high dosages and, accordingly, be well tolerated. The objective current study was investigate safety and efficacy rotigotine transdermal system add-on oral DA patients advanced PD...
Objective: Investigate safety, feasibility and efficacy of switching therapy in patients with advanced-stage Parkinson's disease (PD) inadequately controlled pramipexole (≤ 3.5 mg/day) or ropinirole 14 to rotigotine transdermal system mg/24 h; dose adjustments ≤ 16 h permitted).
This paper aims to examine the association between painful physical symptoms (PPS) and major depressive disorder (MDD) in a naturalistic clinical practice setting within Korean population.Patients with acute MDD that joined multicountry, observational, three-month study six Asian countries regions were classified as PPS+ (mean score >/=2) PPS- <2) using modified Somatic Symptom Inventory. In this analysis, we report results from subset, where depression severity was assessed Clinical Global...
Smad4, Smad6 and Smad7 are important molecules in TGF-beta pathway, which plays an role pancreatic ductal adenocarcinoma (PDAC) biology. Aims : This study examined the expression profiles of mRNA patient samples PDAC their relationship to Smad protein expression, SMAD4 gene mutations, clinicopathological parameters survival.Surgically resected, paired normal tumor tissues 25 patients were studied.Protein levels assessed by immunohistochemistry RT-PCR, respectively.Statistical analysis was...
Objective. To investigate the relationship between changes in attention-deficit/hyperactivity disorder (ADHD) core symptoms and academic outcome of Asian children treated with atomoxetine. Methods. This open-label study enrolled patients aged 8–11 years DSM-IV-TR-defined ADHD, who were naïve to ADHD medications met symptomatic severity threshold 1.5 standard deviations above age gender norm for ADHDRS-IV-Parent:Inv (ADHDRS) total score. Data collection occurred 24 weeks included outcome,...