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

  1. EMA, 2020. Availability of Medicines during covid-19 pandemic. Press briefing – 14 May 2020.
  2. OECD Policy Responses to Coronavirus (COVID-19), COVID-19 and international trade: Issues and actions, Updated 12 June 2020. Accessed on 6 October 2020.
  3. Curran, E. Urgent Demand for Medical Equipment is Making Air Cargo Fees “Absolutely Crazy”, Bloomberg, Accessed on 6 October 2020.
  4. Dasgupta, N, Miglani, S. India Allows Limited Exports of Anti-Malaria Drug After Trump Warns of Retaliation, Reuters , 06 April, 2020. Accessed on 6 October 2020.
  5. Rees, V. India to restrict 10 percent of medicine exports due to coronavirus. Accessed on 6 October 2020.
  6. 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 .
  7. BMJ, 2020. Covid-19: Demand for dexamethasone surges as RECOVERY trial publishes preprint. BMJ 2020; 369: m2512.
  9. Barnes, J. Remdesivir: US buys up almost entire world supply of coronavirus drug. Wednesday 01 July 2020. Accessed on 6 October 2020.

References – Approval of regulatory starting materials

  1. 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.
  2. FDA. Guideline for submitting supporting documentation in drug applications for the manufacture of drug substance. Center for drug evaluation and research (CDER), 1987.
  3. ICH Q7A. Good manufacturing practices for active pharmaceutical ingredients. Step 5, CPMP/ICH/4106/00, November 2000.
  4. ICH Q11. Development and Manufacture of Drug Substances. Step 5. EMA/CHMP/ICH/425213/2011, November 2012.
  5. ICH Q11. Development and Manufacture of Drug Substances. Questions and Answers. Step 5. EMA/CHMP/ICH/809509, 01 September 2017.
  6. Q11. Development and Manufacture of Drug Substances. Questions and Answers. Guidance for Industry. February 2018.
  7. 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.
  8. ICH Q3A(R2). Impurities in new drug substances, Step 5. CPMP/ICH/2737/99. October 2006.
  9. 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.
  10. ICH S9. Guideline S9 on nonclinical evaluation for anticancer pharmaceuticals. Step 5. EMA/CHMP/ICH/646107, May 2010.
  11. Seevers RH, Klutz WF.Regulatory strategy for starting material designation.Pharm. Outsourcing. Jan/Feb2010, 11, 1.
  12. Holm R, Elder DP. Analytical advances in pharmaceutical impurity profiling. Eur. J. Pharm. Sci., 87, 2016, 118-135
  13. 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.
  14. 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.
  15. ICH Q2(R1). Validation of analytical procedures: Text and Methodology, Step 5. CPMP/ICH/38/95. June 1995.
  16. 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.
  17. 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.
  18. 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.