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Difficulties in conceiving and applying guidelines for the safety evaluation of biotechnologically-produced drugs: some examples
Notes to applicants for marketing authorizations on the pre-clinical biological safety testing of medicinal products derived from biotechnology (and comparable products derived from chemical synthesis). Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy and Working Party on Safety of Medicines
A human GM-CSF receptor expressed in transgenic mice stimulates proliferation and differentiation of hemopoietic progenitors to all lineages in response to human GM-CSF
Comparative pathology of recombinant murine interferon-gamma in mice and recombinant human interferon-gamma in cynomolgus monkeys
Criteria for investigation of the product equivalence of monoclonal antibodies for therapeutic and in vivo-diagnostic use in case of introduction of changes in the manufacturing process
Design of biological equivalence programs for therapeutic biotechnology products in clinical development: a perspective
Safety assessment of biotechnology-derived pharmaceutical products. General principles and the relevant cases
Protein aggregates seem to play a key role among the parameters influencing the antigenicity of interferon alpha (IFN-alpha) in normal and transgenic mice
Pharmacokinetic and immunogenic behavior of three recombinant human GM-CSF-EPO hybrid proteins in cynomolgus monkeys
'Metabonomics': understanding the metabolic responses of living systems to pathophysiological stimuli via multivariate statistical analysis of biological NMR spectroscopic data
Safety evaluation of immunomodulatory biopharmaceuticals: can we improve the predictive value of preclinical studies?
Effect of dosing schedule on pharmacokinetics of alpha interferon and anti-alpha interferon neutralizing antibody in mice
Analysis of genetic and epigenetic mechanisms of toxicity: potential roles of toxicogenomics and proteomics in toxicology
Modulation of intestinal permeability: a novel and innovative approach for the oral delivery of drugs, macromolecules and antigens
Enhanced fibroblast contraction of 3D collagen lattices and integrin expression by TGF-beta1 and -beta3: mechanoregulatory growth factors?
Overview of known non-human primate pathogens with potential to affect colonies used for toxicity testing
Challenges of general safety evaluations of biologics compared to small molecule pharmaceuticals in animal models
Thirty years of preclinical safety evaluation of biopharmaceuticals: Did scientific progress lead to appropriate regulatory guidance?
Practical approaches to dose selection for first-in-human clinical trials with novel biopharmaceuticals
The application of ICH S6 to the preclinical safety evaluation of plasma derivative therapeutic products
Polymeric carriers: preclinical safety and the regulatory implications for design and development of polymer therapeutics
Developmental toxicity testing of monoclonal antibodies: an enhanced pre- and postnatal study design option
Similar biological medicinal products currently licensed in the European union--overview of non-clinical study programs
Duration of chronic toxicity studies for biotechnology-derived pharmaceuticals: is 6 months still appropriate?
Regulatory acceptance of animal models of disease to support clinical trials of medicines and advanced therapy medicinal products
Considerations in assessing the developmental and reproductive toxicity potential of biopharmaceuticals
Critical evaluation of current developmental toxicity testing strategies: a case of babies and their bathwater
Specific antibody responses of primary cells from different cell sources are able to predict immunotoxicity in vitro
Considerations for assessment of reproductive and developmental toxicity of oligonucleotide-based therapeutics
Quantification of Paclitaxel and Polyaspartate Paclitaxel Conjugate in Beagle Plasma: Application to a Pharmacokinetic Study
Applicability of predictive toxicology methods for monoclonal antibody therapeutics: status Quo and scope
Goldilocks' Determination of What New In Vivo Data are "Just Right" for Different Common Drug Development Scenarios, Part 1
Allogeneic adipose-derived stem cells with low immunogenicity constructing tissue-engineered bone for repairing bone defects in pigs
Commentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products
Resolution of unexpected pregnancy-related findings in a rat embryofetal development and toxicokinetic study of monoclonal antibodies specific for hCMV
Anti-Arrhythmic Drug Therapies
Anti-arrhythmic drugs are used to prevent abnormal heart rhythms. These medications are used in conditions including, ventricular tachycardia, ventricular fibrillation and atrial fibrillation. Discover the latest research on anti-arrhythmic drug therapies here.
Bioinformatics in Biomedicine
Bioinformatics in biomedicine incorporates computer science, biology, chemistry, medicine, mathematics and statistics. Discover the latest research on bioinformatics in biomedicine here.