European Pharmaceutical Review

JANUARY 26, 2023

The ICH M10 guideline provides recommendations on the validation of bioanalytical assays for chemical and biological drugs and their metabolites in biological matrices. These concentration measurements are used as part of regulatory decisions regarding the safety and efficacy of medicinal products.

Food and Drug Administration 98

Food and Drug Administration Medicine Pharmaceutical products Pharmaceutical 98

European Pharmaceutical Review

AUGUST 9, 2022

According to researchers, a ribB -based colorimetric loop-mediated isothermal amplification (LAMP) assay could become a fast and easy-to-perform detection method for testing non-sterile pharmaceuticals for BCC. Burkholderia species are one of the primary causes of non-sterile pharmaceutical product recalls and accounted for 45.3

Food and Drug Administration 98

Food and Drug Administration Pharmaceutical products Pharmaceutical Pharmaceutical manufacturing 98

European Pharmaceutical Review

JANUARY 9, 2024

Accelerated drug discovery: Simulations and predictive models powered by AI will speed up the drug development process, effectively slashing time to market for drugs. Internet] US Food and Drug Administration (FDA). 2019; 380(14):1347-1358. 2019; 16(9):1297-1299. 2023; 44(3):1384-1392.

Pharmaceutical manufacturing 122

Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

Management 97

Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 97

European Pharmaceutical Review

APRIL 21, 2023

In addition, the number of active substances detected in the environment has been increasing with unknown consequences for ecosystems and the accumulation of substances in food chains. Giving environmental risk assessments teeth Since 2005, the authorisation of a human pharmaceutical product requires an environmental risk assessment (ERA).

Pharma 98

Pharma Food and Drug Administration Medicine Pharmaceutical 98

European Pharmaceutical Review

AUGUST 23, 2022

The prevalence of fake drugs is a continually growing problem worldwide. Fake drugs can be categorised as substandard, falsified, counterfeit and diverted drugs, and the World Health Organization (WHO) broadly defines a counterfeit medicine as “one which is deliberately and fraudulently mislabelled with respect to identity and/or source.”

Medicine 98

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 98

European Pharmaceutical Review

FEBRUARY 3, 2025

The US Food and Drug Administration (FDA) has sent a warning letter to KVK-Techs drug manufacturing facility following an inspection in April 2019. The document identified significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals.

Manufacturing 88

Manufacturing Food and Drug Administration FDA Food 88