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

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

Pharmaceutical Technology

MARCH 22, 2023

In recent times, suppliers have also chosen other systems that rely on blockchain and sensors to track drug supply and reduce the influx of counterfeit drugs. In recent times, various global administrators have issued regulatory standards. Why the use of RFID has fluctuated over the past decade?

Food and Drug Administration 105

Food and Drug Administration Electronics Pharma Pharmaceutical products 105

European Pharmaceutical Review

APRIL 21, 2023

2022; 6: 949-57. Hence, every country that looks at decarbonising its health sector – and all EU Member States must – will quickly look at the pharmaceutical industry. 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

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. 1 Following in vitro production from T cells collected from a patient’s leukapheresis procedure, the CAR T cells are infused back into the patient’s blood, where they proliferate and expand.

Manufacturing 104

Manufacturing Food and Drug Administration Patients Pharma 104

European Pharmaceutical Review

OCTOBER 19, 2022

Patents are often described as the ‘lifeblood’ of pharmaceutical companies. 1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment.

Food and Drug Administration 96

Food and Drug Administration Pharmaceutical products Pharmaceutical FDA 96

European Pharmaceutical Review

JANUARY 16, 2023

This Q&A covers the key developments in pharmaceutical microbiology in 2022, featuring insight from pharmaceutical microbiology experts: Dr Tim Sandle, Head of Microbiology, Bio Products Laboratory Limited. Regulation, particularly Annex 1, was identified as a key focus for 2022.

Pharmaceutical 128

Pharmaceutical Food and Drug Administration Manufacturing Medicine 128