Roots Analysis
MARCH 1, 2023
Genotoxicity testing refers to the evaluation of detrimental effects of chemical or physical agents on the genetic processes and related hereditary material of living cells. Mechanism of Genotoxicity / Mutagenicity The interaction of genotoxins / mutagens with the structure of DNA causes damage to the genetic material.
Camargo
DECEMBER 22, 2021
In addition, the size and complexity of a development program can vary significantly depending on product characteristics, market dynamics, and regulatory pathway. These studies can be a critical inflection point for strategy, value, and investment and typically form the basis for market approval. Fine-Tuning Strategic Assessment.
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Camargo
APRIL 20, 2021
Sponsors can select the patient population and leverage companion diagnostics, and nonclinical study requirements such as genotoxicity and carcinogenicity studies can often be waived or delayed to later stages of development, especially for end-stage cancer therapies.
Pharmaceutical Technology
JUNE 26, 2022
Streamlined processes to reduce time to market for drugs. When asked about some key processes that Quotient Sciences provides to clients that help streamline drug substance development and reduce time to market, Castledine states that the key improvement is the drug substance to drug product integration.
The Pharma Data
FEBRUARY 8, 2021
Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1%
The Pharma Data
MARCH 25, 2021
Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1%
FDA Law Blog
OCTOBER 10, 2023
Having a clear understanding of FDA’s data expectations for 510(k) applications related to implants is crucial for successful marketing clearance. subacute/subchronic toxicity, genotoxicity, implantation, hemocompatibility, chronic toxicity, carcinogenicity, reproductive/developmental toxicity and degradation).
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