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In general, beta-blocking agents should be avoided in patients withovert congestive failure. However, in some patients with compensated cardiac failure it may benecessary to utilize them. Concurrent use of rifampin increases the metabolic clearance of ZEBETA, resulting in a shortenedelimination half-life of ZEBETA. However, initial dose modification is generally not necessary.Pharmacokinetic studies document no clinically relevant interactions with other agents givenconcomitantly, including thiazide diuretics and cimetidine.

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ZEBET follows a three-fold strategy to improve information dissemination on alternative methods to animal experiments that consists of (1) capturing of and supply with information, (2) education in reliable search procedures, and (3) research in retrieval technology. Of the adverse events listed in the table, bradycardia, diarrhea, asthenia, fatigue, and sinusitisappear to be dose related. Embarking on your ZEbet journey begins with a seamless registration process that’s designed for your convenience. Whether you’re on a desktop or on the move with your mobile device, the ZEbet platform is tailored to your preferences. On their website, simply click the ‘Register’ button and populate the required fields with your personal details. The process is just as intuitive on the ZEbet app, where a few taps guide you through the sign-up seamlessly.

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In the following, an Expert Meeting on the “Current Scientific and Legal Status of Alternative Methods to the LD50 Test for Botulinum Neurotoxin (BoNT) Potency Testing” was held at the BfR on April 27–28, 2009 (Adler et al. 2010). Experts from industry, regulatory authorities, German ministries, academia, national and international validation centers, and animal welfare organizations were invited to actively participate in the meeting. Similarly, at the heart of the idea of performance standards for test guidelines was the acute problem of loss of suppliers for two human reconstituted skin models during their early validation for testing for skin corrosivity (Balls 1997). Performance standards define global criteria that a test method is expected to fulfill, independent of a specific test setup. To emphasize the importance of performance standards, we may look at the achievements in the automobile industry.

Scientists in the European countries planning to conduct animal experiments are obliged to undertake a valid “indispensability search” prior to applying for an authorization of the experiment at the national competent authority. Only when the availability of a suitable alternative or of usable scientific results have been excluded based upon the current state of knowledge, an animal experiment may be authorized. The experimental validation of any new or updated toxicological test method requires examining both its intra- and inter-laboratory reproducibility as well as its performance in the prediction of toxic properties to humans. The translation of test method readouts into human health predictions requires prediction models which are often based on biostatistical methods. Thus, prediction models are crucial components of test methods as they must guarantee correct predictions about new substances for the purpose of human health protection.

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An internationally harmonized testing helps companies and their products to be competitive in the global marketplace in addition to preventing unnecessary repeated testing on live animals or in vitro. On the occasion of the 20th anniversary of the Center for Alternative Methods to Animal Experiments (ZEBET), an international symposium was held at the German Federal Institute for Risk Assessment (BfR) in Berlin. Another topic addressed by the symposium was the new vision on “Toxicology in the twenty-first Century”, as proposed by the US-National Research Council, which aims at using human cells and tissues for toxicity testing in vitro rather than live animals. An overview of the achievements and current tasks, as well as a vision of the future to be addressed by ZEBET@BfR in the years to come is outlined in the present paper. Ethical concerns have been raised in both Europe and the US about the animal suffering in BoNT potency testing, especially in the context of BoNT’s cosmetic applications. As a result, the BMELV commissioned ZEBET to assess the status of the different existing alternative methods to the BoNT LD50 potency test and the most promising approaches for their validation.

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The main areas of use are in basic science (33%) and research and development (31%), followed by production and quality control for medical products, substances, or devices (15%). In patients with cirrhosis of the liver, the elimination of ZEBETA (bisoprolol fumarate) is morevariable in rate and significantly slower than that in healthy subjects, with plasma half-life ranging from8.3 to 21.7 hours. Beta-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia.Nonselective beta-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serumglucose levels. However, patientssubject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemicagents, should be cautioned about these possibilities and bisoprolol fumarate should be used withcaution. Exacerbation of angina pectoris, and, in some instances, myocardial infarction or ventricular arrhythmia,have been observed in patients with coronary artery disease following abrupt cessation of therapy withbeta-blockers. Such patients should, therefore, be cautioned against interruption or discontinuation oftherapy without the physician’s advice.

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• Beta1-selectivity of ZEBETA has been demonstrated in both animal and human studies.
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• Atenolol is used to treat angina (chest pain) and hypertension (high blood pressure).
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• Due to these improvements, this new molecular method holds promise as a sensitive, more rapid and reproducible screen highly suited to predict developmental toxicity in vivo from in vitro data (Buesen et al. 2009).

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Currently, the serotypes BoNT-A and BoNT-B are used as active ingredients in licensed drugs for the treatment of a variety of medical disorders such as cervical dystonia, blepharospasm, spastic conditions, and hyperhidrosis. However, BoNT is also used in so-called “esthetic medicine” to temporarily treat facial asymmetries or reduce facial lines. BoNT’s pharmacological activity is extraordinarily high which, due to its biological origin, varies from batch to batch. Therefore, it is not only a question of potency but also of drug safety that the biological activity of BoNT needs to be determined as accurately as possible. Overall, significantly greater blood pressure reductions were observed on bisoprolol fumarate than onplacebo regardless of race, age, or gender. There were no significant differences in response betweenblack and nonblack patients.

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Again, if this bookmaker wishes to remain competitive, they must add additional contact methods such as live chat and telephone contact. The BoNT EWG comprises experts from European regulatory authorities, 3R-related and validation institutions, manufacturers, and scientists. It will meet regularly several times per year during a proposed time frame of 4 years.

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• The main areas of use are in basic science (33%) and research and development (31%), followed by production and quality control for medical products, substances, or devices (15%).
• Before going into what ZEBET’s future might look like, it is worthwhile to assess the status quo and to praise what has been achieved during the first 20 years at this German institution.
• The more recent TG 439 comprises three elements for performance standards, essential test method components, a minimum list of twenty reference chemicals, and defined reliability and accuracy values.
• Currently, the serotypes BoNT-A and BoNT-B are used as active ingredients in licensed drugs for the treatment of a variety of medical disorders such as cervical dystonia, blepharospasm, spastic conditions, and hyperhidrosis.
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There was no effect of ZEBETA onprothrombin time in patients on stable doses of warfarin. As with other beta-blockers, ANA conversions have also been reported on bisoprolol fumarate. About15% of patients in long-term studies converted to a positive titer, although about one-third of thesepatients subsequently reconverted to a negative titer while on continued therapy.

The first pass metabolism of bisoprolol fumarate is about 20%.not affected by the presence of food. The first pass metabolism of bisoprolol fumarate is about 20%.Binding to serum proteins is approximately 30%. Peak plasma concentrations occur within 2-4 hours ofdosing with 5 to 20 mg, and mean peak values range from 16 ng/mL at 5 mg to 70 ng/mL at 20 mg. Oncedaily dosing with bisoprolol fumarate results in less than twofold intersubject variation in peak plasmalevels. The plasma elimination half-life is 9-12 hours and is slightly longer in elderly patients, in partbecause of decreased renal function in that population. In both young and elderly populations, plasma accumulation is low; the accumulationfactor ranges from 1.1 to 1.3, and is what would be expected from the first order kinetics and once dailydosing.

• Sympathetic stimulation is a vital component supporting circulatory function in the setting of congestiveheart failure, and beta-blockade may result in further depression of myocardial contractility andprecipitate more severe failure.
• The expression profile in response to a new substance is then compared to the signature database, and by similarity a mode of action, including off-target effects, can be predicted (Fig. 10).
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• Bisoprolol fumarate is not metabolized by cytochrome P450 II D6(debrisoquin hydroxylase).
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Patients, especially those with coronary artery disease, should be warned about discontinuing use ofZEBETA without a physician’s supervision. Patients should also be advised to consult a physician ifany difficulty in breathing occurs, or if they develop signs or symptoms of congestive heart failure orexcessive bradycardia. In normal volunteers, ZEBETA therapy resulted in a reduction of exercise- and isoproterenol-inducedtachycardia. Effects persisted for 24 hoursat doses equal to or greater than 5 mg. The most prominent effect of ZEBETA is the negative chronotropic effect, resulting in a reduction inresting and exercise heart rate. There is a fall in resting and exercise cardiac output with little observedchange in stroke volume, and only a small increase in right atrial pressure, or pulmonary capillarywedge pressure at rest or during exercise.

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• About15% of patients in long-term studies converted to a positive titer, although about one-third of thesepatients subsequently reconverted to a negative titer while on continued therapy.
• Bisoprolol fumarate is eliminated equally by renal and non-renal pathways with about 50% of the doseappearing unchanged in the urine and the remainder appearing in the form of inactive metabolites.
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• For neural cell development, we could demonstrate that mouse embryonic stem cells can be efficiently differentiated in vitro into cell types present in the nervous system like mature neurons, astrocytes, and oligodendrocytes (Seiler et al. 2006b).

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• In rats, bisoprolol fumarate was not teratogenic at doses up to 150 mg/kg/day which is 375 and 77 timesthe MRHD on the basis of body weight and body surface area, respectively.
• This obligation considers the internationally accepted 3Rs concept that was laid out by Russel and Burch in 1959.

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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Zebeta only for the indication prescribed. Other drugs may interact with bisoprolol, including prescription and over-the-counter medicines, vitamins, and herbal products.

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The latter values represent the sensitivity, specificity, and accuracy of current methods, and any new method has to perform equal Zebet or better. The largest share of animals required for toxicology and safety testing of 42% was used for acute and sub-acute toxicity testing (Commission of the European Communities 2007). A second large fraction of 17.7% was used for testing carcinogenicity, mutagenicity, and toxicity to reproduction (CMR) (Fig. 6) (Commission of the European Communities 2007).

Already in 1990, an international committee under participation of ZEBET convened to develop a scientific concept for the experimental validation of toxicological testing methods (Balls et al. 1990). Followed by two similar workshops (Balls et al. 1995), and two OECD workshops in 1996 and 2002 (Organisation for Economic Co-Operation, Development 1996, 2002), this ultimately led to the OECD Guidance Document No. 34 finally ratified in 2005. In addition, this exemplifies the long process of introducing new OECD guidelines, which is in part due to the fact that a unanimous consensus has to be found. ZEBET scientists are involved in the development of OECD Test Guidelines (TG) and Guidance Documents (GD), which has led to an improvement in the welfare of laboratory animals (Table 1).