Navigation Links
Nonclinical and Clinical Safety Assessment of Biosimilars, New Webinar Hosted by Xtalks
Date:7/15/2013

Toronto, Canada (PRWEB) July 15, 2013

The development of Biosimilars has gained momentum in recent years due to upcoming patent expiry of first generation Biologics and increasing financial pressure on health care systems. Consequently, regulatory frameworks are evolving in various countries to guide a path for Biosimilar drug development, however, the complex nature of Biopharmaceuticals makes the demonstration of Biosimilarity with regard to quality, safety and efficacy extremely challenging.

Based on the specific aspects of Biosimilar drug development and registration, the development strategies differ significantly from the development of an innovator product that has to establish both the efficacy and safety independently from other products.

The webinar will review the current regulatory landscape and guidance for nonclinical and clinical development of Biosimilars with a focus on safety-related aspects and discuss the current challenges and future perspectives in this area.

A live Q&A with the audience will follow the main presentation. For more information, or to register for this event please go to http://xtalks.com/biosimilars-safety-assessment.ashx

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://www.xtalks.com

Contact:
Zayeeta Dasgupta, M.Sc in Life Science and Business Ma
'/>"/>

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Page: 1 2

Related biology technology :

1. PointCross Life Sciences Opens New Office in Silver Spring, Maryland for Data Standardization of Nonclinical Studies
2. ChemoCentryx Presents Positive Results for Novel CCR2 Inhibitor in Preclinical Models of Diabetic Nephropathy at the 44th Annual Meeting of the American Society of Nephrology
3. Positive Clinical Study Results for BSPs HyperQ Technology
4. DermTechs Non-invasive Melanoma Detection Assay Poised to Enter Clinical Validation Study
5. Nile Therapeutics Announces Top-Line Results in Clinical Trial Evaluating the Subcutaneous Infusion of Cenderitide, Meets Primary Endpoint
6. AtheroNova Inc. Preclinical Study Demonstrates 95% Reduction in Arterial Plaque Formation
7. A New Type of Dendritic Cell-Based Cancer Vaccine has Received Approval for Clinical Tests and at the Same Time Secures Substantial Financing
8. Generex Provides Update on Generex Oral-lyn™ Clinical & Regulatory Program
9. US Oncology Research Affiliated Physician to Present Findings From Innovative Clinical Trial at 2011 CTRC-AACR San Antonio Breast Cancer Symposium
10. TetraLogic Pharmaceuticals Announces Initiation of a Phase 1/2 Clinical Trial of TL32711 in Patients with Acute Myelogenous Leukemia (AML)
11. Echo Therapeutics Announces Positive Results of Clinical Trial of its Symphony® Transdermal Continuous Glucose Monitoring (tCGM) System in Patients With Type 1 and Type 2 Diabetes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/22/2014)... Involution Studios , a healthcare software design ... Understanding Ebola . The goal of the ... follow informative tool for anyone wanting to know more ... , "As the news has spread in all directions ... not only a healthcare crisis with global impact, but ...
(Date:10/22/2014)... October 22, 2014 Physicians Choice ... cardiovascular pharmacogenetics menu, which enables healthcare providers to ... With PCLS’s evidence-based results, healthcare providers are better ... their therapy, while minimizing risks for adverse drug ... according to the FDA [1] more than 2.2 ...
(Date:10/22/2014)... -- Nuvilex, Inc. (OTCQB: NVLX) – According to the ... living with diabetes, with  that number expected to grow ... for diabetes treatments is approximately $500 billion.  ... pancreatic cancer.  Pancreatic cancer is the fourth most common ... the United States , and according to a ...
(Date:10/20/2014)... Oct. 20, 2014 Mapp Biopharmaceutical,s valiant ... antibody therapeutic to fight the Ebola outbreak will ... time-consuming the production of pharmaceuticals can be, according ... said that while some may be taken aback ... those with industry knowledge are well aware of ...
Breaking Biology Technology:Involution Studios' Ebola Infographic Provides Key Disease Information and Statistics at a Glance 2PCLS Announces Expansion of Cardiovascular Pharmacogenetic Testing Menu 2PCLS Announces Expansion of Cardiovascular Pharmacogenetic Testing Menu 3Nuvilex Brief Analyst Report: Thinking Outside the Box by BrokerBank Securities, Inc. 2Kalorama: ZMapp Highlights Need For Faster Biopharmaceutical Production 2Kalorama: ZMapp Highlights Need For Faster Biopharmaceutical Production 3
... it has become the majority owner of First Choice ... the greater Harrisburg area. First Choice,s 13 clinics join ... providing high-quality rehabilitation in outpatient settings. ... as Select Physical Therapy will offer physical therapy and ...
... offering best-in-class clinical, commercial and consulting services to the ... a definitive agreement to acquire certain promotional and medical ... committed to divest in connection with obtaining regulatory approval ... transaction were not disclosed. The business will ...
... 17, 2012 Using growth factors derived from a ... Charles Runels have developed a simple, office-based procedure that ... sexual response. The preliminary results of this procedure, which ... a specific area on the upper wall of the ...
Cached Biology Technology:First Choice Rehabilitation Specialists Joins Select Medical 2inVentiv Health to Acquire SDI Promotional and Medical Audit Businesses From IMS Health 2inVentiv Health to Acquire SDI Promotional and Medical Audit Businesses From IMS Health 3inVentiv Health to Acquire SDI Promotional and Medical Audit Businesses From IMS Health 4inVentiv Health to Acquire SDI Promotional and Medical Audit Businesses From IMS Health 5"O-Shot™" May Improve Female Sexual Response 2"O-Shot™" May Improve Female Sexual Response 3
(Date:10/14/2014)... in Cancer Research shows SIRT6—a protein known ... promote the development of skin cancers by turning on ... sun-damaged skin cells. , Previously considered protective, SIRT6 is ... that help regulate genomic stability and prevent some of ... DNA damage, which can lead to cancer. This study, ...
(Date:10/14/2014)... – Scientists have sequenced the house fly genome for ... might expect from an insect that thrives in pathogen-rich ... Oct. 14 in the journal Genome Biology , ... and of how flies quickly adapt to resist insecticides, ... house flies (Musca domestica) carry and transmit more than ...
(Date:10/14/2014)... Sinai-led research team has discovered a new kind of stem ... cell that lines liver blood vessels, according to a study ... The existence of such a cell type contradicts current theory ... and may hold clues to origins of, and future treatment ... a single cell into a complex being made up of ...
Breaking Biology News(10 mins):Two-faced gene: SIRT6 prevents some cancers but promotes sun-induced skin cancer 2House fly genome reveals expanded immune system 2Stem cell discovery challenges dogma on how fetus develops; holds insights for liver cancer and reg 2Stem cell discovery challenges dogma on how fetus develops; holds insights for liver cancer and reg 3
... -- When melatonin, a hormone secreted by the ... stem cells (MSCs) prior to their transplantation into the ... researchers in China found that the stem cells survived ... 80 percent of transplanted MSCs died within 72 hours ...
... of losers and a few lucky winners. This is the ... fish called Fouldenia , which first appears in the ... that wiped out more than 90 percent of the planet,s ... 359 million years ago created opportunities quickly exploited by a ...
... a body is like building a houseif you compromise structural ... a cellular level than in the case of epithelial sheets, ... the gut to mammary glands. As long as epithelial cells ... of building tissue barriers and constructing ducts goes smoothly. But ...
Cached Biology News:Melatonin pre-treatment is a factor that impacts stem cell survival after transplantation 2Melatonin pre-treatment is a factor that impacts stem cell survival after transplantation 3From obscurity to dominance: Tracking the rapid evolutionary rise of ray-finned fish 2From obscurity to dominance: Tracking the rapid evolutionary rise of ray-finned fish 3From obscurity to dominance: Tracking the rapid evolutionary rise of ray-finned fish 4A flip of the mitotic spindle has disastrous consequences for epithelial cells 2A flip of the mitotic spindle has disastrous consequences for epithelial cells 3A flip of the mitotic spindle has disastrous consequences for epithelial cells 4
... MDR1 Shift Assay provides a convenient method to ... transport of MDR1 substrates. Thus, the kit may ... small molecules act as transport substrates for MDR1. ... presence of MDR1 substrates, the MDR1 Shift Assay ...
... The wide and long ... of Polaroid gel documentation systems. ... holds the camera in place ... that allows photography on the ...
... tissue microarrays are derived from Paraffin embedded ... quality control procedures to ensure the highest ... assembled in one block, sectioned at a ... coated slides. Sections are large (3-5 mm ...
... from frozen embedded tissue blocks, which are ... ensure the highest quality. Tissues of each ... sectioned at a thickness of 7microns and ... (3-5mm in diameter) in comparison to core ...
Biology Products: