Genotoxicity and Production - Clinical Research Informer

The Composition and Value of a Portfolio Analysis

Camargo

DECEMBER 22, 2021

One of Camargo’s differentiating offerings is the portfolio analysis, a high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability of each product within a sponsor’s portfolio. Each product is unique, and so is the associated development strategy. Why Conduct a Portfolio Analysis?

Bioequivalency

Bioequivalency Production Genotoxicity In-Vivo

Artificial Smoke Flavoring in Food: EU Ban and Industry Impact

XTalks

JUNE 21, 2024

The European Union (EU) recently introduced a ban on eight artificial smoke flavorings used in various food products. The ban targets artificial smoke flavorings linked to genotoxicity concerns. Genotoxicity involves damage to genetic material within cells, increasing cancer and inherited disease risks.

Genotoxicity

Genotoxicity Regulation Production Manufacturing

IN FOCUS: Solvias

Pharmaceutical Technology

DECEMBER 9, 2022

M&A – Commended PRODUCT LAUNCHES – Commended RESEARCH AND DEVELOPMENT – Commende d. The company is ranked in the M&A, PRODUCT LAUNCHES and RESEARCH AND DEVELOPMENT categories in the 2022 Pharmaceutical Technology Excellence Rankings. Pharmaceutical Technology Excellence Rankings – The Verdict.

Development

Development Production Manufacturing Vaccine

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Development of Oncology Therapies – Tips from the FDA to Drive Success

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. Build a Pitch and Team That Appeal to Investors. A strong IP position.

Development

Development Genotoxicity Production Drugs

Moving off the critical path: Streamlining strategies for drug substance synthesis and manufacturing

Pharmaceutical Technology

JUNE 26, 2022

Placing traditionally siloed drug substance and drug product development activities within a single organization that also has commercial manufacturing capabilities accelerates clinical development and builds in quality and robustness of supply. Integrated drug substance and drug product services. Polymorphic form issues.

Manufacturing

Manufacturing Drugs Production Development

The Future for Biotesting

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

In-Vitro Genotoxicity In-Vivo Development

Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy. Container Closure Systems. shaking, changes in pressure, etc.).

Packaging

Packaging Packaging Containment Production

PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

The Pharma Data

FEBRUARY 8, 2021

This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Food and Drug Administration (FDA). This extension does not include potential pediatric exclusivity.

HR

HR Clinical Trials Clinical Trials Containment

FIRST-LINE IBRANCE® (PALBOCICLIB) COMBINATION THERAPY IN HR+, HER2- METASTATIC BREAST CANCER

The Pharma Data

MARCH 25, 2021

Chief Development Officer, Oncology, Pfizer Global Product Development. 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.

HR

HR Clinical Trials Clinical Trials Trials

Treatment of Metastatic Triple-Negative Breast Cancer

The Pharma Data

MARCH 25, 2021

The MAA is now under accelerated review by the EMA, in recognition of the product being considered of major interest for public health and therapeutic innovation. SG contains a genotoxic component and can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. Embryo-Fetal Toxicity.

Genotoxicity

Genotoxicity Genotype Containment Protein

Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival

The Pharma Data

APRIL 7, 2021

TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. The European Medicines Agency has also validated a Marketing Authorization Application for Trodelvy in the European Union. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

HR

HR Genotype FDA Approval Genotoxicity

FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

FDA Law Blog

OCTOBER 10, 2023

subacute/subchronic toxicity, genotoxicity, implantation, hemocompatibility, chronic toxicity, carcinogenicity, reproductive/developmental toxicity and degradation). Particulate Characterization Assessment of “the body’s response to any associated degradation products, including those leached from wear debris.”

In-Vivo

In-Vivo Manufacturing Engineer Genotoxicity

Let's Quit Sugar With Audiobook – Let's Quit Sugar

The Pharma Data

MAY 13, 2021

Product Name: Let's Quit Sugar With Audiobook – Let's Quit Sugar. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked.

Insulin

Insulin Production Hormones Medicine

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog

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

Manufacturing Genotoxicity Containment Regulation

Clinical Research Informer

The Composition and Value of a Portfolio Analysis

Artificial Smoke Flavoring in Food: EU Ban and Industry Impact

Webinars

Trending Sources

IN FOCUS: Solvias

Webinars

Development of Oncology Therapies – Tips from the FDA to Drive Success

Moving off the critical path: Streamlining strategies for drug substance synthesis and manufacturing

The Future for Biotesting

Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

FIRST-LINE IBRANCE® (PALBOCICLIB) COMBINATION THERAPY IN HR+, HER2- METASTATIC BREAST CANCER

Treatment of Metastatic Triple-Negative Breast Cancer

Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival

FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

Let's Quit Sugar With Audiobook – Let's Quit Sugar

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

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