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.

Antibody 130

Antibody RNA Vaccination Vaccine 130

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.

Development 137

Development Genotoxicity Drugs Clinical Trials 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 RNA Genotoxicity 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 (..)

Drugs 130

Drugs Manufacturing Genotoxicity Bioavailability 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 Drugs 98

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.

Genotoxicity 130

Genotoxicity In-Vitro In-Vivo Clinical Research 130

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 Medicine Protein 52

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

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.

Clinical Trials 52

Clinical Trials Clinical Trials Genotoxicity Drugs 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.

FDA Approval 52

FDA Approval Genotype Medicine Genotoxicity 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 FDA Approval Drugs Genotoxicity 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 Drugs Medicine Hormones 52