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Legrand M.,Environment Canada | Feeley M.,Health Products and Food Branch | Tikhonov C.,First Nations and Inuit Health Branch | Schoen D.,Environment Canada | Li-Muller A.,Environment Canada
Canadian Journal of Public Health

Exposure to methylmercury (MeHg) from fish and marine mammal consumption continues to present a public health concern. To date, developmental neurotoxicity is the most sensitive health outcome, forming the basis for health-risk assessments and the derivation of biomonitoring guidance values. This article summarizes existing Health Canada MeHg blood guidance values for general population and expands them to include a harmonized provisional interim blood guidance value of 8 μg/L based on the existing provisional Tolerable Daily Intake for children, pregnant women and women of childbearing age. Associated public health actions, according to age, sex, and level of exposure are recommended. © 2010 Canadian Public Health Association. Source

Knezevic I.,World Health Organization | Griffiths E.,Health Products and Food Branch

Biotechnology derived medicinal products are presently the best characterized biologicals with considerable production and clinical experience, and have revolutionized the treatment of some of the most difficult-to-treat diseases, prolonging and improving the quality of life and patient care. They are also currently one of the fastest growing segments of the pharmaceutical industry market. The critical challenge that the biopharmaceutical industry is facing is the expiry of patents for the first generation of biopharmaceuticals, mainly recombinant DNA derived products, such as interferons, growth hormone and erythropoetin. The question that immediately arose was how should such copies of the originator products be licensed, bearing in mind that they are highly complex biological molecules produced by equally complex biological production processes with their inherent problem of biological variability. Copying biologicals is much more complex than copying small molecules and the critical issue was how to handle the licensing of products if relying in part on data from an innovator product. Since 2004 there has been considerable international consultation on how to deal with biosimilars and biological copy products. This has led to a better understanding of the challenges in the regulatory evaluation of the quality, safety and efficacy of " biosimilars" , to the exchange of information between regulators, as well as to the identification of key issues. The aim of this article is to provide a brief overview of the scientific and regulatory challenges faced in developing and evaluating similar biotherapeutic products for global use. It is intended as an introduction to the series of articles in this special issue of Biologicals devoted to similar biotherepeutic products. © 2011. Source

Omnitrope is the first Subsequent Entry Biologic (SEB)/Similar Biotherapeutic Product (SBP) filed with Health Canada, for purposes of marketing. Health Canada is the home organization of the Regulatory Authority in Canada. As the first SEB to be filed for actual review, it presented unique challenges. While the principles for the review and approval of a SEB were laid out in a " fact sheet" there remained still a guidance to be drafted. The review of the submissions proceeded in parallel with the development of the guideline. This article will provide the details of how the final decision was arrived at and how that decision validated the principles underlying the guidance document, in the absence of direct regulations specifically addressing SEBs in Canada. © 2011. Source

Sevinc M.S.,Healthy Environments and Consumer Safety Branch | Kumar V.,Healthy Environments and Consumer Safety Branch | Abebe M.,Healthy Environments and Consumer Safety Branch | Lemieux M.,Health Products and Food Branch | Vijay H.M.,Healthy Environments and Consumer Safety Branch
Medical Mycology

A ribosomal P1 protein, Pen b 26 from Penicillium brevicompactum, was previously identified as a major allergen. A homolog protein was isolated and characterized from Penicillium crustosum which is not known to be allergenic mold. A cDNA library of P. crustosum was constructed and screened using a probe based on the DNA sequence of Pen b 26. A positive clone was isolated, expressed in Escherichia coli, purified and characterized by comparing its immunological and physical properties to Pen b 26. It was designated as Pen cr 26 and had a 321 nt ORF corresponding to 107 amino acids with a MW of 11 kDa. Pen cr 26 had strong sequence homology to Pen b 26 (92% for nucleotides and 86% for amino acids) and its physical and predicted structural properties were similar to the latter. The level of expression of Pen cr 26 was much lower than that of Pen b 26 in the same expression vector. Both proteins were recognized equally well by the IgG class specific antibodies, but Pen cr 26 was poorly recognized by Penicillium-sensitive atopic sera (IgE), suggesting striking antigenic difference in IgE epitopes, i.e., 87% were positive for Pen b 26 while only 23% were positive for Pen cr 26. The allergenicity of Pen cr 26 seems to be minor in nature and it could be a hypoallergenic variant of Pen b 26. © 2013 The International Society for Human and Animal Mycology. All rights reserved. Source

Arbuckle T.E.,Health Canada | Fraser W.D.,University of Montreal | Fisher M.,Health Canada | Davis K.,Health Canada | And 54 more authors.
Paediatric and Perinatal Epidemiology

Background The Maternal-Infant Research on Environmental Chemicals (MIREC) Study was established to obtain Canadian biomonitoring data for pregnant women and their infants, and to examine potential adverse health effects of prenatal exposure to priority environmental chemicals on pregnancy and infant health. Methods Women were recruited during the first trimester from 10 sites across Canada and were followed through delivery. Questionnaires were administered during pregnancy and post-delivery to collect information on demographics, occupation, life style, medical history, environmental exposures and diet. Information on the pregnancy and the infant was abstracted from medical charts. Maternal blood, urine, hair and breast milk, as well as cord blood and infant meconium, were collected and analysed for an extensive list of environmental biomarkers and nutrients. Additional biospecimens were stored in the study's Biobank. The MIREC Research Platform encompasses the main cohort study, the Biobank and follow-up studies. Results Of the 8716 women approached at early prenatal clinics, 5108 were eligible and 2001 agreed to participate (39%). MIREC participants tended to smoke less (5.9% vs. 10.5%), be older (mean 32.2 vs. 29.4 years) and have a higher education (62.3% vs. 35.1% with a university degree) than women giving birth in Canada. Conclusions The MIREC Study, while smaller in number of participants than several of the international cohort studies, has one of the most comprehensive datasets on prenatal exposure to multiple environmental chemicals. The biomonitoring data and biological specimen bank will make this research platform a significant resource for examining potential adverse health effects of prenatal exposure to environmental chemicals. © 2013 John Wiley & Sons Ltd and Her Majesty the Queen in Right of Canada. Reproduced with the permission of the Minister of Health. © 2013 John Wiley & Sons Ltd. Source

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