Compliance and Genotoxicity - Clinical Research Informer

Search:

DAY

WEEK

MONTH

YEAR

Select your country:
Sign up | Log in

Compliance

Genotoxicity

The Composition and Value of a Portfolio Analysis

Camargo

DECEMBER 22, 2021

A nonclinical safety evaluation program typically includes pharmacology, general toxicity, toxicokinetics, nonclinical PK, reproductive toxicity, genotoxicity, and carcinogenesis. These are put in place to ensure product quality in compliance with FDA requirements. Chemistry, Manufacturing, and Controls (CMC) Strategies.

Bioequivalency

Bioequivalency Production Genotoxicity In-Vivo

Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

XTalks

MAY 13, 2022

Depending on the type of product or study scope, there are three main approaches for E&L evaluations (the approach selected depends on the purpose or application, and the FDA branch the submission falls under): Pharmaceutical Containers Closure Systems: involves compliance with USP <661.2>, > umbrella).

Packaging

Packaging Packaging Containment Production

The Composition and Value of a Portfolio Analysis

Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

Stay Connected