The Pharma Data

MAY 3, 2021

The International Council for Harmonization (ICH) recently announced that its guideline establishing new permitted daily exposures (PDEs) for three residual solvents had reached Step 4, meaning the guideline can now be implemented by regulators. .

Genotoxicity 40

Genotoxicity Regulation Manufacturing Drugs 40

Drug Discovery World

JANUARY 10, 2024

These therapies, which exhibit substantial long-term side effects, including genotoxicity and an increased predisposition to secondary cancers, have significantly higher rates of subsequent malignancies than the rate reported for patients following CAR-T cell immunotherapies.

Gene Therapy 59

Gene Therapy Genotoxicity Gene Genetics 59

Pharmaceutical Technology

DECEMBER 9, 2022

Our laboratories operate to the highest quality standards under international organisation for standardisation (ISO), good manufacturing practice (GMP), good laboratory practice (GLP) and US Food and Drug Administration (FDA) regulations. Quality control release testing.

Development 130

Development Manufacturing Production Vaccination 130

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 130

In-Vitro Genotoxicity In-Vivo Clinical Research 130

XTalks

MAY 13, 2022

Container closure systems are highly regulated by health agencies. USP and EP Organizations for Container Regulation. If they do, the FDA will assume the worst-case scenario and deem the compound or fragment to be genotoxic or eugenic. shaking, changes in pressure, etc.). Requirements for Primary Packaging Components.

Packaging 98

Packaging Packaging Containment Production 98

FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

In-Vivo 45

In-Vivo Manufacturing Engineer Genotoxicity 45

The Pharma Data

MARCH 25, 2021

IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Pfizer will continue to share new data from these studies with the scientific community as results becomes available.

HR 52

HR Clinical Trials Clinical Trials Trials 52