European Pharmaceutical Review

JANUARY 26, 2023

The European Medicines Agency (EMA) has published an updated Q&A document regarding ICH M10 ‘Bioanalytical Method Validation and Study Sample Analysis’. 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

Pharmaceutical Technology

MARCH 10, 2023

Freeze drying is a crucial technique to prolong the shelf life of pharmaceutical products. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state.

Pharmaceutical 59

Pharmaceutical Leads Manufacturing Pharmaceutical products 59

European Pharmaceutical Review

MARCH 12, 2024

Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. Good documentation practices. Use of advanced technologies. How can this be mitigated? What is an effective solution?

Government 98

Government Pharma Training Ethics 98

Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products.

Leads 52

Leads Marketing Pharmaceutical Medicine 52

Pharmaceutical Technology

OCTOBER 28, 2022

QbD principles are woven into regulatory guidance documents, primarily guidances Q8 to Q11 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Practising QbD in biosimilar product development. Following QbD to guarantee a drug product's safety.

Manufacturing 52

Manufacturing Safety Medicine Pharmaceutical 52

Clarivate

MARCH 14, 2024

With the introduction of a new CMC Intelligence entitlement to address post-approval changes, Clarivate now covers a broader range of the lifecycle of pharmaceutical products. Future research could focus on developing PFAS-free packaging materials that meet regulatory standards without compromising safety.

Pharmaceutical 52

Pharmaceutical Manufacturing Food Healthcare Provider 52

European Pharmaceutical Review

DECEMBER 19, 2023

7 The additional substantial economic benefits that flow from room-temperature storability have also been thoroughly documented. TRS 953 – Annex 2, Appendix 1: Stability testing of active pharmaceutical ingredients and finished pharmaceutical products: Stability conditions for WHO Member States by Region. Internet] WHO.

Distribution 111

Distribution Manufacturing Food Pharmaceutical 111