Search Results - "Klein, Agnes V."

Regulatory Decision Making in Canada—Exploring New Frontiers in Patient Involvement by Klein, Agnes V., MD, DPH, Hardy, Stephanie, MPH, Lim, Robyn, PhD, Marshall, Deborah A

“…Abstract Recent legislative amendments aim to enhance the transparency of the regulatory review processes about drugs, and provide public information about…”
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Biosimilar monoclonal antibodies: A Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation by Scott, Bradley J., Klein, Agnes V., Wang, Jian

“…Monoclonal antibodies have become mainstays of treatment for many diseases. After more than a decade on the Canadian market, a number of authorized monoclonal…”
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Regulatory Verification by Health Canada of Content in Recombinant Human Insulin, Human Insulin Analog, and Porcine Insulin Drug Products in the Canadian Market Using Validated Pharmacopoeial Methods Over Nonvalidated Approaches by Lorbetskie, Barry, Bigelow, Stewart, Walrond, Lisa, Klein, Agnes V., Loo, Shih-Miin, Green, Nancy, Rosu-Myles, Michael, Zhang, Xu, Lu, Huixin, Girard, Michel, Sauvé, Simon

“…Background: For diabetes mellitus treatment plans, the consistency and quality of insulin drug products are crucial for patient well-being. Because biologic…”
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Impaired awareness of hypoglycemia in a man with type 1 diabetes by Plourde, Gilles, Klein, Agnes V, Dent, Robert

“…Physicians should ask about the frequency and timing of severe hypoglycemia, personal awareness of hypoglycemia, signs of hypoglycemia detected by others and…”
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Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases by Epps, Carla, Bax, Ralph, Croker, Alysha, Green, Dionna, Gropman, Andrea, Klein, Agnes V, Landry, Hannah, Pariser, Anne, Rosenman, Marc, Sakiyama, Michiyo, Sato, Junko, Sen, Kuntal, Stone, Monique, Takeuchi, Fumi, Davis, Jonathan M

“…The literature thoroughly describes the challenges of pediatric drug development for rare diseases. This includes (1) generating interest from sponsors, (2)…”
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The first subsequent entry biologic authorized for market in Canada: The story of Omnitrope, a recombinant human growth hormone by Klein, Agnes V.

“…Omnitrope is the first Subsequent Entry Biologic (SEB)/Similar Biotherapeutic Product (SBP) filed with Health Canada, for purposes of marketing. Health Canada…”
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Health Canada/BIOTECanada Summit on regulatory and clinical topics related to subsequent entry biologics (biosimilars), Ottawa, Canada, 14 May 2012 by Kay, Jonathan, Feagan, Brian G., Guirguis, Micheal S., Keystone, Edward C., Klein, Agnes V., Lubiniecki, Anthony S., Mould, Diane R., Nyarko, Kwasi A., Ridgway, Anthony A.G., Trudeau, Maureen E., Wang, Jian

“…In May 2012, Health Canada and other participants held a National Summit on Subsequent Entry Biologics (SEBs). Health Canada released a guidance document in…”
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Biosimilars: State of Clinical and Regulatory Science by Klein, Agnes Victoria, Wang, Jian, Feagan, Brian G, Omoto, Mark

“…On May 12, 2017, various issues and challenges associated with biologics were discussed during a session of the annual joint conference of Canadian Society for…”
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A new toolkit for conducting clinical trials in rare disorders: will this dog hunt? by Peterson, Robert G, Macleod, Stuart M, Klein, Agnes V

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