Dave Elder European Pharmaceutical Review references Issue 5 2020
References for ‘Availability of critical medicines during pandemics’ and ‘Approval of regulatory starting materials’, in European Pharmaceutical Review Issue 5 2020.
References – Availability of critical medicines during pandemics
- EMA, 2020. Availability of Medicines during covid-19 pandemic. Press briefing – 14 May 2020.
- OECD Policy Responses to Coronavirus (COVID-19), COVID-19 and international trade: Issues and actions, Updated 12 June 2020. http://www.oecd.org/coronavirus/policy-responses/covid-19-and-international-trade-issues-and-actions-494da2fa/. Accessed on 6 October 2020.
- Curran, E. Urgent Demand for Medical Equipment is Making Air Cargo Fees “Absolutely Crazy”, Bloomberg, https://www.bloomberg.com/news/articles/2020-03-30/-absolutely-crazy-air-cargo-fees-highlight-supply-chain-squeeze Accessed on 6 October 2020.
- Dasgupta, N, Miglani, S. India Allows Limited Exports of Anti-Malaria Drug After Trump Warns of Retaliation, Reuters , 06 April, 2020. https://uk.reuters.com/article/us-health-coronavirus-india-drugs/india-allows-limited-exports-of-anti-malaria-drug-after-trump-warns-of-retaliation-idUKKBN21O34B. Accessed on 6 October 2020.
- Rees, V. India to restrict 10 percent of medicine exports due to coronavirus. https://www.europeanpharmaceuticalreview.com/news/114484/india-to-restrict-10-percent-of-medicine-exports-due-to-coronavirus/. Accessed on 6 October 2020.
- Romano, S, Galante, H, Figueria D, Mendes, Z, Rodriguea, AT. Time-trend analysis of medicine sales and shortages during COVID-19 outbreak: Data from community pharmacies. Res. Social Adm. Pharm. 2020 May 23. doi: 10.1016/j.sapharm.2020.05.024 .
- BMJ, 2020. Covid-19: Demand for dexamethasone surges as RECOVERY trial publishes preprint. BMJ 2020; 369: m2512.
- Blackman, M. HOSPITALS AND HEALTH SYSTEMS STOCK UP ON PANDEMIC MEDICATIONS FOR POTENTIAL SECOND WAVE. https://www.healthleadersmedia.com/strategy/hospitals-and-health-systems-stock-pandemic-medications-potential-second-wave. Accessed on 6 October 2020.
- Barnes, J. Remdesivir: US buys up almost entire world supply of coronavirus drug. Wednesday 01 July 2020. https://www.independent.co.uk/news/world/americas/us-politics/remdesivir-coronavirus-drug-us-buy-world-supply-price-gilead-a9594781.html. Accessed on 6 October 2020.
References – Approval of regulatory starting materials
- Faul MM, Kiesman WF, SmulkowskiM, Pfeiffer S, et al. Part 1: A review and perspective of the regulatory guidance to support designation and justification of API starting material. Org. Proc. Res. Dev., 18, 2014, 587-593.
- FDA. Guideline for submitting supporting documentation in drug applications for the manufacture of drug substance. Center for drug evaluation and research (CDER), 1987.
- ICH Q7A. Good manufacturing practices for active pharmaceutical ingredients. Step 5, CPMP/ICH/4106/00, November 2000.
- ICH Q11. Development and Manufacture of Drug Substances. Step 5. EMA/CHMP/ICH/425213/2011, November 2012.
- ICH Q11. Development and Manufacture of Drug Substances. Questions and Answers. Step 5. EMA/CHMP/ICH/809509, 01 September 2017.
- Q11. Development and Manufacture of Drug Substances. Questions and Answers. Guidance for Industry. February 2018.
- Teasdale A, Elder DP, Chang S-J, Wang S et al. Risk assessment of genotoxic impurities (GTIs) in new chemical entities-strategies to demonstrate control.Org. Proc. Res. Dev., 17(2), 2013, 221-230.
- ICH Q3A(R2). Impurities in new drug substances, Step 5. CPMP/ICH/2737/99. October 2006.
- ICHM7(R1). Guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk, Step 5. EMA/CHMP/83812/2013. February 2018.
- ICH S9. Guideline S9 on nonclinical evaluation for anticancer pharmaceuticals. Step 5. EMA/CHMP/ICH/646107, May 2010.
- Seevers RH, Klutz WF.Regulatory strategy for starting material designation.Pharm. Outsourcing. Jan/Feb2010, 11, 1.
- Holm R, Elder DP. Analytical advances in pharmaceutical impurity profiling. Eur. J. Pharm. Sci., 87, 2016, 118-135
- Li X, Stoll DR, Carr PW. A simple and accurate equation for peak capacity estimation in two-dimensional liquid chromatography. Anal. Sci., 81(2), 2009, 845-850.
- Faul MM, Busacca CA, Eriksson MC, Hicks F, et al. Part 2: Designation and justification of API starting materials: Current practices across member companies of the IQ consortium.Org. Proc. Res. Dev., 18, 2014, 594-600.
- ICH Q2(R1). Validation of analytical procedures: Text and Methodology, Step 5. CPMP/ICH/38/95. June 1995.
- Faul MM, Argentine MD, Egan M, Eriksson MC, et al. Part 3: Designation and justification of API starting materials: Proposed framework for alignment from an industry perspective. Org. Proc. Res. Dev., 19, 2015, 915-924.
- WigmanL, Schulte Oestrich R, Hildbrand S, Iwamura H, et al. A new risk assessment tool for regulatory starting material evaluation. Amer. Pharm. Rev., 16 March 2017.
- ReizmanBJ, Burt JL, Frank SA, Argentine MD, et al. Data-driven prediction of risk in drug substance starting materials. Org. Proc. Res. Dev., 23, 2019, 1429-1441.