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Carcinogenicity Studies and Services Carcinogenicity Studies and Services

Carcinogenicity Studies and Services

We provide services for standard or customized carcinogenicity studies.

We offer carcinogenicity studies to identify the tumorigenicity potential of New Chemical Entities (NCEs). We conduct carcinogenicity testing in rats and mice as per the standard or customized study protocols. Carcinogenicity studies may be included as a separate arm in a combined chronic toxicity or carcinogenicity study design.

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Facilities

The in-life phase of the carcinogenicity studies is performed by a group of experienced toxicologists in AAALAC accredited animal facility. Our clinical pathology and histopathology laboratories are state-of-the-art facilities equipped with GLP compliant instruments from internationally reputed suppliers. The computerized systems used in our laboratories are validated and fit for purpose as required by the Principles of GLP.

To support formulation analysis and bioanalysis, the toxicology laboratory coordinates with co-located GLP compliant analytical and DMPK team.

Why Aurigene Pharmaceutical Services?

Standard or custom carcinogenicity studies

State-of-the-art facilities

Fit-for-purpose and GLP compliant instruments

Expert team of scientists

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“Bathtub Chemistry” - Necessity and Aspects of Process Research

MAY 19, 2023

“Bathtub Chemistry” - Necessity and Aspects of Process Research

Medicine is an essential part of our life. Since ancient time human civilization has been tirelessly engaged to understand the cause and effect of a disease. Sometimes they win and many times they loss. But the story of their curiosity and enthusiasm is a never damping process. On the contrary it increases day by day, year after year.    &nbsp...

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Building successful long-term partnerships with CDMOs from early drug discovery through commercialization

 Maximizing efficiency in drug research, development, and manufacturing is crucial for turning new innovations into therapeutic and financial benefits. Over the past couple of decades, pharmaceutical companies have increasingly turned to contract development and manufacturing organizations (CDMOs) for collaborations as they seek more adaptable capacity and c...

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How the re-designed synthesis of a complex carbohydrate can reduce cycle time

Project challenge: Complex carbohydrate chemistry involving a linear sequence of 10 chemical transformations, unstable intermediates and column chromatographic purications. Solution design: Process research and optimization was performed to develop a robust and scalable process which was implemented on commercial scale. Telescoping of reactions reduced the number...

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Alternate end-game strategies towards Nirmatrelvir synthesis: Defining a continuous flow process for the preparation of an anti-COVID drug

2023

Scalable alternate end-game strategies for the synthesis of the anti-COVID drug molecule Nirmatrelvir (1,PF-07321332) have been described. The first involves a direct synthesis of 1 via amidation of the carboxylic acid 7 (suitably activated as a mixed anhydride with either pivaloyl chloride or T3P) with the ...

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