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Assessing the Immunogenicity of Biopharmaceuticals
Factors associated with immunogenicity of biopharmaceuticals, potential clinical ramifications, and current regulatory guidance for evaluating Immunogenicity are reviewed, and methods to assess immunogeniability in non-clinical and clinical studies are discussed. Expand
Cardiodigin: endogenous digitalis-like material from mammalian heart.
[Clinical and pharmacokinetic comparison of 2 oral preparations of nifedipine: 10 mg capsules and 20 mg delayed-release tablets].
Pharmacokinetic data indicate that, in most subjects, nifedipine therapeutics plasma levels (over 15 ng/ml) can be maintained with the administration of a 20 mg slow release tablet every 12 hours, and suggest that this formulation is the adequate alternative in chronic treatments with nifingipine, such as arterial hypertension. Expand
THU0124 Variability of Intended Copies for Etanercept in Five Countries
None of the ICs analyzed meet the combination of release specification and additional characterization criteria Pfizer typically apply to support a comparability assessment with ETN, although each product met some of the requirements. Expand
[Characterization of an endogenous factor with digitalic activity in the guinea pig heart (II): Binding to a receptor].
The data suggest that the activity of the extract was due to the presence of a factor that recognizes the digitalis binding site but not to ions nor lipids, which support the hypothesis of the existence of an endogenous ligand of thedigitalis receptor in mammals that could be a physiological regulator of the sodium pump. Expand
Adverse Drug Reactions Associated with Anthracyclinebased Chemotherapy in Mexican Cancer Pediatric Patients: Cohort Study
Introduction. Adverse drug reactions (ADR) are an important cause of illnesses and death in cancer pediatric patients. Anthracyclines are drugs used as the first-line treatment for this disease. ItExpand
[Pharmacokinetics and antihypertensive effect of pelanserin in dogs ].
The pharmacokinetic and pharmacodynamic profiles of pelanserin allow to predict that this drug could have a place in the therapeutics of arterial hypertension, and the observed effect was not only due to an action at peripheral level, but other mechanisms could likely be involved. Expand
[Characterization of an endogenous factor with digitalis-like activity in the heart of the guinea pig (I): Inhibition of Na,K-ATPase)].
The results support the hypothesis on an endogenous factor exhibiting digitalis-like activity that could be a physiological regulator of the sodium pump. Expand