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Genotoxicity Services
27 services found
Manufactured by:CD Formulation based inShirley, NEW YORK (USA)
Genotoxic Impurities Test: The control of genotoxic impurities is a complex and delicate project throughout the whole life cycle of drug development, and an important part of it is the assessment of genotoxic impurities. The study of genotoxic impurities involves a combination of organic chemistry, biochemistry, toxicology, ...
Manufactured by:Environmental Bio-Detection Products Inc. (EBPI) based inBurlington, ONTARIO (CANADA)
In addition to the specific mutagenicity assays provided by EBPI Analytics, a line of general genotoxicity tests are offered. These assays use modified bacteria that have the induction of a SOS DNA response gene coupled to a gene that expresses a measurable colorimetric endpoint. The degree of induction of the SOS response can be quantified by the degree of colour change, and ...
Manufactured by:Molecular Biology Resources, Inc. based inMilwaukee, WISCONSIN (USA)
MBR offers assay services to investigate the effects of drug compounds on key DNA replication and repair enzymes, such as human DNA polymerase α (alpha), human DNA polymerase β (beta), human DNA polymerase γ (gamma), and HeLa cell extracts (containing replication protein ...
by:Affygility Solutions based inBroomfield, COLORADO (USA)
Have a pharmaceutical product that needs a formal genotoxic and carcinogenic impurity assessment to meet the requirements of ICH M7? The expert toxicologists at Affygility Solutions can assist your ...
Manufactured by:Gentronix Ltd based inCheshire, UNITED KINGDOM
The Ames test, a bacterial reverse mutation assay, is the most commonly requested genotoxicity study in regulatory testing frameworks and has been in use for decades. The test investigates the ability of test substances to cause specific mutations in Salmonella or E. coli strains that allow them to then grow on selective agar plates. ...
Manufactured by:Gentronix Ltd based inCheshire, UNITED KINGDOM
The mouse lymphoma assay is one of the mammalian gene mutation assays available and is frequently utilised in most genotoxicity testing regulatory frameworks. Able to detect point mutations, clastogens, and in some cases aneugens; the mouse lymphoma assay has an advantage compared to the HPRT (the alternative mammalian gene mutation assay) due to its capability to detect a ...
Manufactured by:Gentronix Ltd based inCheshire, UNITED KINGDOM
The in vitro micronucleus test (MNT) is a main-stay of most regulatory genotoxicity testing strategies, and is used to detect in vitro clastogens and aneugens. In this regard it complements the Ames test well, as between the two study types they detect all of the three major classes of genotoxin. Fluorescence In Situ Hybridisation (FISH) can also be conducted to differentiate ...
Manufactured by:Alfa Chemistry based inNew York, NEW YORK (USA)
Reproductive Toxicology Laboratory: Reproductive development and genotoxicity studies are important elements in the safety evaluation of new drugs. With a wealth of control data accumulated over the years and a professional and stable research team, Alfa Chemistry's reproductive toxicology laboratory can provide clients with a full range of reproductive and developmental toxicity ...
Manufactured by:Regis Technologies Inc. based inMorton Grove, ILLINOIS (USA)
Regulatory agencies have acknowledged impurities, especially potential genotoxic impurities (PGIs), as a high priority in the drug development approval process. Since impurities found in pharmaceutical drug substances can potentially exhibit pharmacological activity, there are reporting, identification, and qualification thresholds dictated by ICH guidelines. ...
Manufactured by:BIOHIDRICA Biotecnologias del Agua Ltda. based inSantiago, CHILE
Water Pollution: Assembly and Development of Ecotoxicity and Genotoxicity ...
Manufactured by:SEQENS Group based inÉcully, FRANCE
Highly potent compounds, Steroids and Cytotoxics manufacturing capabilities. Read more. Oligonucleotides. Analytical Methods Development. Synthesis of Impurities and Standards. Potential Genotoxic Impurities Evaluation including High Sensitivity Analytical Methods. Solid State (Polymorphism screening / Salts / Co-Crystals). Read more. Characterization of Physical Properties. ...
Manufactured by:Creative Bioarray based inShirley, NEW YORK (USA)
S9 stability assay and hepatocyte stability assay are also available at Creative Bioarray. Liver S9 fraction (Cat. CSC-C4093X) as a product can be used in genotoxicity tests such as the Ames test as a metabolic ...
by:Bibra Toxicology Advice & Consulting based inWallington, UNITED KINGDOM
Our hazard assessments, generally based on in-depth searches of the scientific literature, aim to define the dose-response for all routes of each of a chemical’s toxicological propensities, for example its carcinogenicity, genotoxicity, or ability to disrupt reproduction. We summarise all of the available data in a transparent format, taking into account the needs of ...
by:EBRC Consulting GmbH based inHannover, GERMANY
Based on the available or new newly generated data, the CSA will be performed under consideration of the following ...
Manufactured by:Regis Technologies Inc. based inMorton Grove, ILLINOIS (USA)
For over 50 years, Regis has been a premier custom small molecule manufacturer with excellent analytical support services. Regis’ analytical capabilities are now available to customers requiring stand alone pharmaceutical services. Our Analytical Method Development team (AMD) consists of highly skilled analytical chemists talented in developing and validating phase appropriate methods. Let ...
Manufactured by:Echelon Biosciences, Inc (EBI) based inSalt Lake City, UTAH (USA)
The Hyaluronic Acid (HA) Screening Service uses the HA-ELISA kit (K-1200) to quantify HA in biological samples. Hyaluronic acid (HA) is a high molecular weight anionic polysaccharide (1,000-10,000 kD) composed of repeating disaccharides. Many chronic liver diseases, including infection, toxicity, genetic, autoimmunity, and malignancy result in liver inflammation and an increase in circulating HA ...
Manufactured by:BIOHIDRICA Biotecnologias del Agua Ltda. based inSantiago, CHILE
Tests are performed according national (NCh) or internationals (ISO, USEPA, OECD and ASTM) ...
Manufactured by:Environmental Bio-Detection Products Inc. (EBPI) based inBurlington, ONTARIO (CANADA)
Biomedical and environmental regulatory toxicology encompasses the collection, processing, and evaluation of experimental toxicology data to permit educated decisions on protecting and maintaining human and environmental health against harmful effects caused by natural and synthetic chemical substances. To make these types of decisions, a battery of assays need to be performed and professionals ...
Manufactured by:Environmental Bio-Detection Products Inc. (EBPI) based inBurlington, ONTARIO (CANADA)
Biomedical and environmental regulatory toxicology encompasses the collection, processing, and evaluation of experimental toxicology data to permit educated decisions on protecting and maintaining human and environmental health against harmful effects caused by natural and synthetic chemical substances. To make these types of decisions, a battery of assays need to be performed and professionals ...
Manufactured by:InnoSer Belgie NV based inDiepenbeek, BELGIUM
In vitro and in vivo methods to provide a study setup that thoroughly determines safety and efficacy. ...