Genotoxicity is an adverse effect of a chemical on genetic material via variety of mechanisms, including mutation. In vitro Genotoxicity testing is very crucial to determine potential carcinogenic or mutagenic compounds that can cause genetic alterations in somatic or germ cells, and this information is used in regulatory decision-making. Mutagenicity (gene mutation and structural and numerical chromosomal alterations) is one of the six basic testing areas that have been adopted by the Organization for Economic Co-operation and Development (OECD, 2011) as the minimum requirement to screen high-production volume chemicals for toxicity.
Three Major Endpoints of Genetic Damage
- Gene mutation (i.e. point mutations or deletions or insertions that affect single or blocks of genes)
- Clastogenicity (i.e. structural chromosome changes)
- Aneuploidy (i.e. the occurrence of one or more extra or missing chromosomes, leading to an unbalanced chromosome complement).
In vitro Genotoxicity Testing
- Bacterial reverse mutation test (OECD 471)
- In vitro chromosomal aberration test using human blood lymphocytes (OECD 473)
- In vitro micronucleus test using human blood lymphocytes (OECD 487)
- Mammalian cell gene mutation assay (OECD 490)
Why Aurigene Pharmaceutical Services?
Combination of tests to assess genetic damage
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Hyderabad R and D Center
Bangalore R and D Center
Peptide Synthesis
Resources
Oligonucleotide as a novel class of therapeutic modality
Oligonucleotides as a therapeutic class is a revolutionary approach to discover new and important therapeutic agents for treating human diseases. RNA-based intervention at times works in cases where other modalities do not work. For example, it may help in treating inborn errors in metabolism, genetic disorders and rareOligonucleotide therapeutics is the use of c...
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HPAPI Molecule from Development to Market
The global Highly Potent Active Pharmaceutical Ingredients (HPAPI) market is expected to reach USD 26.84 Billion by 2023 from USD 17.72 Billion in 2018, at a CAGR 8.7%....
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Gastro Retentive Dosage Form
Introduction: An orally-available anti-diabetic candidate that simultaneously targets all three key organs of diabetes: Pancreas, Liver and Muscles. This drug targets the two main defects seen in patients with type 2 diabetes: The pancreas by increasing insulin secretion, in a glucose-dependent manner; and the muscles and liver by decreasing the excess production...
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A metal catalyst-free and one-pot synthesis of (3,4- dihydro-2H-benzo[b][1,4]oxazin-2-yl)methanol derivatives in water
2015
A robust and metal catalyst-free method has been developed for the general and green synthesis of racemic (3,4-dihydro-2H-benzo[b][1,4] oxazin-2-yl)methanol derivatives. This simple, mild and practical method involves the reaction of 2-aminophenols with ()-epichlorohydrin in the presence of NaOH in water at room temperature. The reaction features high regioselec...
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A simple RP-HPLC method development and verification of the Dissolution of Bromelain-A Complex mixture of proteolytic enzymes, in delayed release tablets
2005
Bromelain is a complex natural mixture of proteolytic enzymes derived from pineapple (Ananas cosmosus), which has good therapeutic properties. Bromelain can be found in all tissues of pineapple plants, including the stem, fruit, and leaves. Bromelain plays an important role in the treatment of many diseases such as soft tissue inflammation and edema, deep derma, ...
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A sensitive and a simple RP-HPLC method development and verification for the quantitative estimation of Cholecalciferol in tablets
2005
Cholecalciferol, also known as Vitamin D3, is widely prescribed for the treatment osteomalacia and osteoporosis [1]. It also plays a key role in calcium and phosphorus homeostasis and skeletal mineralization [2]. IUPAC name of Cholecalciferol is (3β, 5Z, 7E) 9,10-secocholesta-5,7,10(19)-trien-3-ol, whose molecular weight is 384.64 g/mol and its molecular formula...
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A simple RP-HPLC method development and verification for the quantitative estimation of Sodium Butyrate in tablets
2005
Sodium butyrate is the sodium salt of butyric acid (Fig. 1), which exhibits various properties such as immune system modulator, antioxidant, and anti-inflammatory properties [1]. Furthermore, sodium butyrate is used as a promoter of growth in milk replacer formula for young calves [2]....
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