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.

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Genotoxicity DNA Genetics Bacteria 52

BioTech 365

MARCH 10, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: PCR-test reveals risk of genotoxity of genome editing. from European Biotechnology – first and foremost in European biotech [link].

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Genotoxicity Genome Genomics Research 40

BioTech 365

AUGUST 5, 2020

Number of Tests Accepted per Day is Limited to Ensure Rapid Turnaround Time AUSTIN, Texas–(BUSINESS WIRE)–#coronavirus–Genotox Laboratories, an Austin, Texas based company, has announced the capacity to complete 1,500 COVID-19 tests per day.

Genotoxicity 40

Genotoxicity 40

Medical Xpress

FEBRUARY 3, 2023

Fraunhofer researchers have succeeded in using the bioresorbable silica gel Renacer to produce an electrospun membrane that is neither cytotoxic to cells nor genotoxic. This model mimics fibrous structures found in connective tissue and is therefore particularly suitable for regenerative applications, such as for improved wound healing.

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Genotoxicity Research 75

Camargo

DECEMBER 22, 2021

A nonclinical safety evaluation program typically includes pharmacology, general toxicity, toxicokinetics, nonclinical PK, reproductive toxicity, genotoxicity, and carcinogenesis. Nonclinical Requirements. Chemistry, Manufacturing, and Controls (CMC) Strategies.

Bioequivalency 169

Bioequivalency Production Genotoxicity In-Vivo 169

XTalks

JUNE 21, 2024

The ban targets artificial smoke flavorings linked to genotoxicity concerns. Genotoxicity involves damage to genetic material within cells, increasing cancer and inherited disease risks. The EFSA concluded that the majority of assessed smoke flavorings posed genotoxicity risks.

Genotoxicity 52

Genotoxicity Regulation Production Manufacturing 52

The Pharma Data

MAY 3, 2021

According to a Step 4 training presentation on the guideline, the Q3C (R8) Expert Working Group (EWG) review of available toxicity data with 2-MTHF, also known as tert -butylmethyl ether, found no evidence for genotoxicity or reproductive toxicity and no observed effect level in repeat dose toxicity studies involving rats.

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Genotoxicity Regulation Manufacturing Drugs 40

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.

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Development Genotoxicity Production Drugs 137

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 Animals were administered molnupiravir for longer and at higher doses (mg/Kg) than those employed in human studies.

Trials 69

Trials In-Vivo Genotoxicity RNA 69

Pharmaceutical Technology

JUNE 26, 2022

Quotient Sciences’ capabilities in drug substance services include: PR&D Analytical method development and validation Salt selection and polymorph screening Non-GMP, GMP, and commercial drug substance manufacturing Pre-formulation development DoE Thermal hazard and reactivity assessment Stability testing Proven acceptable range (PAR) and critical (..)

Manufacturing 130

Manufacturing Drugs Production Development 130

XTalks

MAY 13, 2022

FDA prefers the use of DEREK, a knowledge-based expert system for the qualitative prediction of toxicity, and SARAH, a statistical software to identify potentially toxic chemicals for assessment of genotoxic and sensitization potential. Tox Tree and grouping by Cramer rules are starting to lose favor with the FDA. Analytical Instrumentation.

Packaging 98

Packaging Packaging Containment Production 98

FDA Law

OCTOBER 10, 2023

subacute/subchronic toxicity, genotoxicity, implantation, hemocompatibility, chronic toxicity, carcinogenicity, reproductive/developmental toxicity and degradation).

In-Vivo 45

In-Vivo Manufacturing Engineer Genotoxicity 45

Pharmaceutical Technology

SEPTEMBER 10, 2008

NC: What are the most recent developments in your genotoxicity studies and which are proving most successful? IS: Our genotoxicity testing includes the core battery of the tests requested by EMEA/ICH including mutagenicity in vitro, chromosomal aberration test in vitro and micronucleus test in vivo.

In-Vitro 100

In-Vitro Genotoxicity In-Vivo Clinical Research 100

Pharmaceutical Technology

DECEMBER 9, 2022

Dedicated experts in extractables and leachables and genotoxic impurities (GTIs) deploy organic trace analysis by liquid chromatography-mass spectrometry (LC-MS), as well as gas chromatography-mass spectrometry (GC-MS) equipment. All our equipment is in line with the latest European Medicines Agency (EMA) and FDA methods.

Development 130

Development Production Manufacturing Vaccination 130

The Pharma Data

MARCH 25, 2021

IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Advise females of reproductive potential to use effective contraception during IBRANCE treatment and for at least 3 weeks after the last dose. Advise male patients to consider sperm preservation before taking IBRANCE.

HR 52

HR Clinical Trials Clinical Trials Trials 52

The Pharma Data

MARCH 25, 2021

SG contains a genotoxic component and can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. Embryo-Fetal Toxicity. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

Genotoxicity 52

Genotoxicity Genotype Containment Protein 52

The Pharma Data

APRIL 14, 2021

TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

Genotype 52

Genotype Containment FDA Approval Genotoxicity 52

The Pharma Data

APRIL 7, 2021

TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

HR 52

HR Genotype FDA Approval Genotoxicity 52

The Pharma Data

FEBRUARY 8, 2021

IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Advise females of reproductive potential to use effective contraception during IBRANCE treatment and for at least 3 weeks after the last dose. Advise male patients to consider sperm preservation before taking IBRANCE.

HR 52

HR Containment Clinical Trials Clinical Trials 52

The Pharma Data

MAY 13, 2021

Exposure to sorbitol during lactation causes metabolic alterations and genotoxic effects in rat offspring. Proceedings of the National Academy of Sciences of the United States of America. 2012;109(16):5984-5988. DOI: 10.1073/pnas.1120794109. 1120794109. Cardoso FS, Araujo-Lima CF, Aiub CA, Felzenszwalb I. Toxicol Lett. 2016;260:36-45.

Insulin 52

Insulin Production Hormones Medicine 52

FDA Law

NOVEMBER 20, 2024

For FDA submissions, this strategy can be used to evaluate the biocompatibility endpoints acute, subacute, subchronic, and chronic systemic toxicity, genotoxicity, carcinogenicity, and reproductive/developmental toxicity. Data from chemical characterization studies must be evaluated in a separate TRA following ISO 10993-17 guidelines.

Manufacturing 59

Manufacturing Genotoxicity Containment Regulation 59