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However, such testing is not always possible given that for most there are no standardized, commercially available assays and that reactions may be related to metabolites as opposed to more easily tested parent compounds.

Patients with cyanotic congenital heart disease have elevated Epo levels, which can induce erythrocytosis, with subsequent hyperviscosity, exacerbation of heart failure, as well as seizures and thromboembolic events.

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Guidelines for more restricted and safer use of these agents in cancer patients are undergoing modification.

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Food and Drug Administration (FDA) in October 2007, the first of a new class of HIV drugs, the integrase inhibitors, to receive such approval.

None of the currently approved biosimilar growth hormones “settled” for this guideline.

These products are awaiting final marketing approval by the EMEA and so the non-clinical and clinical data presented in the EPARs have not yet been made available to the public.

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Human babies are harder to get for eating, and I imagine that there are laws in China about killing babies for that purpose.

Jetra, kao ustalom i drugi organi, vremenom je podlozna promjenama.

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Mothers should be encouraged to breastfeed their babies for their first year.

The possibility of extrapolating immunogenicity data depends on several factors, including understanding the mode of action, experience with the reference product, the extent of characterization of the reference and proposed product, and the amount and relevance of data collected so far.

Takeshita A, Shinjo K, Higuchi M, Miyawaki S, et al.

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Are there any potential immunotoxicities in humans that will not be predicted in animals and need to be assessed in in vitro studies with human cells or in the clinical studies?

Patients did not differ from controls on measures of working memory, visual memory, or attention and concentration, but were comparatively impaired in verbal memory and information-processing speed.

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So, these tests help a vet determine if the bone marrow is doing what it should be doing.

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The goal will be to demonstrate that the biosimilar product is similar to the reference product in terms of quality, safety and efficacy.

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Components of the container closure system that are migrating into the drug formulation during usual production process and storage Up to now it was believed that leachables are a subset of extractables.

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Because anemia portended poor clinical outcome (Dunphy 1989; Fein 1995; Obralic 1990; Oehler 1990; Reed 1994), it was hypothesized that reversal of anemia itself would improve long-term clinical status.

Hirokawa M, Sawada K, Fujishima N, Nakao S, Urabe A, Dan K, Fujisawa S, Yonemura Y, Kawano F, Omine M, Ozawa K, for the PRCA Collaborative Study Group Long-Term response and outcome following immunosuppressive therapy in thymoma-associated pure red cell aplasia: a nationwide cohort study in Japan for the PRCA collaborative study group.

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