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.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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
MARCH 8, 2021
The totality of the data from these studies indicates that molnupiravir is not mutagenic or genotoxic in in vivo mammalian systems. “We Ridgeback markets EbangaTM for the treatment of Ebola and has a late-stage development pipeline which includes molnupiravir for the treatment of COVID-19.
XTalks
MAY 13, 2022
Curia is a global contract research, development and manufacturing organization (CDMO) that specializes in drug discovery, spanning the entire product lifecycle from target to lead candidate identification, development, manufacturing feasibility, through to commercialization and post-marketing. Analytical Instrumentation.
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).
Expert insights. Personalized for you.
52 
Let's personalize your content