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There is a great interest from global companies who are developing biosimilars to pursue interchangeability designation for commercialization of their products in the US. An interchangeability designation will not only allow the substitutability at the pharmacy level without the intervention of a health care provider but the first sponsor who is able to garner interchangeability designation will also receive 12 months of marketing exclusivity. This paper will highlight our current understanding of FDA expectations with regards to demonstrating interchangeability.
This article was published in the following journal.
Name: Therapeutic innovation & regulatory science
Patients' expectations are considered to play an important role in STN DBS. We explored the relationship between expectations, satisfaction and outcome 6 years after surgery.
Meaningful patient engagement (PE) in medicines development and during the life cycle of a product requires all stakeholders have a clear understanding of respective expectations.
In samples of Americans (N = 273) and Indians (N = 194) paid through Mechanical Turk (Study 1) and British (N = 132) volunteers contacted through Reddit (Study 2), we examined how the Dark Triad...
The aim of current study was to develop a valid and reliable short motorcycle riding behavior questionnaire (SMRBQ) and assess its interchangeability with the original 48-item tool. Through a psychome...
Hexavalent vaccines: increasing options for policy-makers and providers. A review of the data supporting interchangeability (substitution with vaccines containing fewer antigens) and mixed schedules from the same manufacturer.
Combination vaccines improve vaccine uptake and open the infant immunization space for additional vaccines. Hexavalent vaccines have been marketed since 2000. Infanrix hexa (combined diphtheria-tetanu...
Lateral epicondylalgia affects people of both gender between 1 and 3% of the world population, with up to 15% in the working population reaching an average of 12 weeks off work for this re...
The goals of this study are to develop and test an educational intervention to address patients' expectations of long-term outcomes of total hip arthroplasty.
The goal of this research study is to learn if there is a difference between participant's expectations of how well they will perform daily living activities after short-term inpatient reh...
Research has shown that people suffering from MDD tend to maintain dysfunctional expectations despite experiences that disconfirm expectations. Recently, it has been shown that this persis...
Design: Prediction trial, up to 10 sites in Asia and Europe Goal: To better understand the "success" or "failure" after orthopedic trauma surgery by developing a model that ...
Set of expectations that exempt persons from responsibility for their illness and exempt them from usual responsibilities.
Laboratory tests demonstrating the presence of physiologically significant substances in the blood, urine, tissue, and body fluids with application to the diagnosis or therapy of disease.
Cognitive mechanism based on expectations or beliefs about one's ability to perform actions necessary to produce a given effect. It is also a theoretical component of behavior change in various therapeutic treatments. (APA, Thesaurus of Psychological Index Terms, 1994)
Non-invasive method of demonstrating internal anatomy based on the principle that atomic nuclei in a strong magnetic field absorb pulses of radiofrequency energy and emit them as radiowaves which can be reconstructed into computerized images. The concept includes proton spin tomographic techniques.
Combination or superimposition of two images for demonstrating differences between them (e.g., radiograph with contrast vs. one without, radionuclide images using different radionuclides, radiograph vs. radionuclide image) and in the preparation of audiovisual materials (e.g., offsetting identical images, coloring of vessels in angiograms).
BioPortfolio lists over 550 biotechnology products - please open http://www.bioportfolio.com/channels?category_id=5 Direct topic pages: Actos Advair Biopharmaceuticals Biosimilars Biotherapeutics GMO Crops Lipitor ...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...