European Pharmaceutical Review

JULY 5, 2023

The long-awaited PDA TR 43 report provides an approach to a quality decision-making process and represents best practices for the identification and classification of visual nonconformities for (empty) glass containers as pharmaceutical product packaging.

Manufacturing 96

Manufacturing Pharmaceutical manufacturing Pharmaceutical products Pharmaceutical 96

European Pharmaceutical Review

MARCH 11, 2024

Additionally, this can be caused by “poor handling, repackaging, and nonadherence to good manufacturing practices [GMP] during dispensing and packaging have resulted in the microbiological contamination of non-sterile pharmaceutical products.” According to the authors, these were linked to 55 fatal cases of fungal meningitis.

Pharmaceutical 98

Pharmaceutical Food and Drug Administration Manufacturing Pharmaceutical products 98

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. 23 April 2013.

Food and Drug Administration 96

Food and Drug Administration Pharmaceutical products Pharmaceutical FDA 96

European Pharmaceutical Review

FEBRUARY 1, 2024

For at least a decade from 2013 until recently, LDL lowering treatments were stuck on a paradigm of just putting people on statins and not getting LDL levels down to certain goals” CETP inhibitors have been around for a while, but they have unfortunately been unsuccessful in getting onto the market commercially. “For

Pharma 97

Pharma Patients Pharmaceutical Leads 97

European Pharmaceutical Review

JANUARY 16, 2023

The other side is the pipeline of new pharmaceutical products. Prior to November 2013 he worked for Merck Research Laboratories in Summit, New Jersey as the Senior Principal Scientist in early phase drug development. About the authors. Dr Tony Cundell has a PhD in Microbiology from the Lincoln University, New Zealand.

Pharmaceutical 128

Pharmaceutical Food and Drug Administration Manufacturing Medicine 128

European Pharmaceutical Review

DECEMBER 19, 2023

TRS 953 – Annex 2, Appendix 1: Stability testing of active pharmaceutical ingredients and finished pharmaceutical products: Stability conditions for WHO Member States by Region. 2011;29:7122–7124. Sharma D, Khamar S, Cullen A, et al. Innovative Drying Technologies for Biopharmaceuticals. Int J Pharm. US10821210B2 Injections.

Distribution 111

Distribution Manufacturing Food Pharmaceutical 111

European Pharmaceutical Review

DECEMBER 23, 2024

ICH Guideline Q12 On Technical And Regulatory Considerations For Pharmaceutical Product Lifecycle Management. ICH Guideline Q13 On Continuous Manufacturing Of Drug Substances And Drug Products – Scientific Guideline. EMA/CHMP/ICH/353369/2013. EMA/CHMP/ICH/83812/2013. November 2012. EMA/CHMP/ICH/425213/2011.

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Safety Pharmaceutical Manufacturing Management 52