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References for European Pharmaceutical Review, Issue 3 2024

Botanical drugs – what is the best way forward for regulatory and market approval? EPR Issue 3, 2024

  1. Office of Dietary Supplements – Botanical Dietary Supplements Background Information [Internet]. National Institutes of Health (NIH) Available from: https://ods.od.nih.gov/factsheets/BotanicalBackground-Consumer/#:~:text=Medicines%20must%20be%20evaluated%20for
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References – Seeking perfection in an imperfect world – EPR Issue 3, 2024

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References – Improving aseptic connections throughout the manufacturing process – a microbiologist’s perspective – EPR Issue 3, 2024

  1. European Commission. Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use: Annex 1 Manufacture of Sterile Medicinal Products.The Rules Governing Medicinal Products in the European Union, 22 Aug. 2022, Brussels, C (2022) 5938 final.
  2. United States Pharmacopeial Convention. Bioburden Control of Nonsterile Drug Substances and Products.United States Pharmacopeia, General Chapter <1115>, Dec. 2014.
  3. Removal of Endotoxin from Protein in Pharmaceutical Processes. [Internet] American Pharmaceutical Review. 2016. [cited 2024June]. Available from: americanpharmaceuticalreview.com/Featured-Articles/190810-Removal-of-Endotoxin-from-Protein-in-Pharmaceutical-Processes/.
  4. Jornitz MW, et al. Considerations in Sterile Filtration-Part II: The Sterilizing Filter and Its Organism Challenge, A Critique of Regulatory Standards.PDA Journal of Pharmaceutical Science and Technology, BioPhorum Operations Group (BPOG).
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  6. International Society for Pharmaceutical Engineering. Baseline Guide, Vol. 6: Biopharmaceutical Manufacturing Facilities. 3rd ed, ISPE, 2022.

References – Vaccine development – progress in infectious diseases and beyond – EPR Issue 3 2024

  1. New BIO Report Finds More Innovation & Investment Needed in Vaccine Development. [Internet] Bio.org. 2024. [cited 2024May]. Available from: https://www.bio.org/press-release/new-bio-report-finds-more-innovation-investment-needed-vaccine-development
  2. A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals’ Herpes Zoster Subunit (HZ/​su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults. [Internet] clinicaltrials.gov. 2024. [cited 2024May]. Available from: https://clinicaltrials.gov/ct2/show/NCT02723773
  3. Lal H. et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. New England Journal of Medicine. 2015. 372(22); 2087–2096.

References – Endotoxin standards: reflection and recommendation – EPR Issue 3 2024

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References – Understanding cardiopulmonary risk in COPD and opportunities for new treatment modalities – EPR Issue 3 2024

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