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 169

Bioequivalency Production Genotoxicity In-Vivo 169

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 130

Development Production Manufacturing Vaccination 130

Drug Discovery World

JANUARY 10, 2024

ISCT and its leaders firmly agree that the benefits of CAR-T therapies continue to outweigh potential risks in the vast majority of cases and recommends that centres with cell therapy expertise should continue to make commercial CAR-T products available to patients when it appears to be the best option available.

Gene Therapy 59

Gene Therapy Genotoxicity Gene Genetics 59

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 98

Packaging Packaging Containment Production 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.

In-Vitro 130

In-Vitro Genotoxicity In-Vivo Clinical Research 130

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 52

HR Clinical Trials Clinical Trials Containment 52

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 45

In-Vivo Manufacturing Engineer Genotoxicity 45