Drugs and Genotoxicity - Clinical Research Informer

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

Pharmaceutical Technology

JUNE 26, 2022

Drug substance plays a key part in ensuring a drug program achieves its major milestones, keeps to budget and delivers on its corporate goals. To increase the likelihood of clinical success, drug developers must identify challenges and potential red flags early on in the candidate selection stage. Polymorphic form issues.

Manufacturing

Manufacturing Drugs Production Development

The Composition and Value of a Portfolio Analysis

Camargo

DECEMBER 22, 2021

Informed by today’s competitive drug development landscape, as well as by the sponsor’s strategic goals and capabilities, a portfolio analysis involves assessing product concept and differentiation, strategic planning, factoring in unmet patient needs, and estimating timelines and expenses. Incentive Programs. Biowaiver Eligibility.

Bioequivalency

Bioequivalency Production Genotoxicity In-Vivo

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. Become Fluent in the Drug Development “Languages.”.

Development

Development Genotoxicity Production Drugs

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

IN FOCUS: Solvias

Pharmaceutical Technology

DECEMBER 9, 2022

Our comprehensive analytical testing portfolio integrates a broad range of capabilities spanning all stages of drug discovery, development and manufacturing. Solvias is well equipped to provide stability testing for all stages of drug development. Integrated analytical services for pharmaceuticals. Quality control release testing.

Development

Development Production Manufacturing Vaccine

ICH announces sign-off of residual solvent guideline

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.

Genotoxicity

Genotoxicity Regulation Manufacturing Drugs

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

The Pharma Data

FEBRUARY 8, 2021

The PTE certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984. This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration (FDA).

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

Food and Drug Administration more than six years ago, IBRANCE has been prescribed to more than 380,000 patients across more than 100 countries. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. OS data is being collected in the PALOMA-2 randomized clinical trial but is not yet mature.

HR

HR Clinical Trials Clinical Trials Trials

Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

XTalks

MAY 13, 2022

In the US, the Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) offer guidance for the development, application and use of appropriate container closure systems through the integration of analytical tests that ensure product integrity and compatibility. USP <1207.1>:

Packaging

Packaging Packaging Containment Production

Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

The Pharma Data

MARCH 8, 2021

Of 202 treated participants, no safety signals have been identified and of the 4 serious adverse events reported, none were considered to be study drug related. This program included assays such as Big Blue and PIG-a designed to provide a robust measure of a drug or chemical’s ability to induce mutations in vivo.

Trials

Trials In-Vivo Genotoxicity RNA

Trodelvy® for the Treatment of Metastatic Urothelial Cancer

The Pharma Data

APRIL 14, 2021

The FDA’s accelerated approval mechanism enables drugs that treat serious diseases with unmet medical need to be approved based on a surrogate or intermediate clinical endpoint. Premedicate with a two or three drug combination regimen (e.g., TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells.

Genotype

Genotype Containment FDA Approval Genotoxicity

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

The Pharma Data

MAY 13, 2021

Nat Rev Drug Discov. Exposure to sorbitol during lactation causes metabolic alterations and genotoxic effects in rat offspring. The obesity epidemic and food addiction: clinical similarities to drug dependence. J Psychoactive Drugs. Curr Drug Abuse Rev. Am J Clin Nutr. 1992;55(1):151S–154S. PMID: 1728825.

Insulin

Insulin Production Hormones Medicine

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

Food and Drug Administration (FDA) has granted full approval to Trodelvy ® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. DRUG INTERACTIONS.

HR

HR Genotype FDA Approval Genotoxicity

Treatment of Metastatic Triple-Negative Breast Cancer

The Pharma Data

MARCH 25, 2021

Food and Drug Administration (FDA) to treat adult patients with metastatic TNBC who have received at least two prior therapies for metastatic disease. Premedicate with a 2- or 3-drug combination regimen (e.g., SG (under the tradename Trodelvy ® ) received accelerated approval by the U.S. Embryo-Fetal Toxicity.

Genotoxicity

Genotoxicity Genotype Containment Protein

Clinical Research Informer

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

The Composition and Value of a Portfolio Analysis

Trending Sources

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

The Future for Biotesting

IN FOCUS: Solvias

ICH announces sign-off of residual solvent guideline

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

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

Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

Trodelvy® for the Treatment of Metastatic Urothelial Cancer

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

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

Treatment of Metastatic Triple-Negative Breast Cancer

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