eBook: Analytical Method and QC Testing Strategies for Biologics Production - 36

this entirely pragmatic approach to impurity control
to other therapeutic areas, where life expectancy is
equally short, i.e. rare diseases.25
References
1.
14. Elder DP. (2016) Interpreting ICH's evolving residual solvents
guideline, Eur. Pharm. Rev., 21(5); 30-33.
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version dated 16 December 2014.
Jacobson-Kram D, McGovern T. (2007) Toxicological overview of
impurities in pharmaceutical products. Adv. Drug Deliv. Rev., 59;
38-42.
2. Elder DP, Teasdale A. (2015) Is Avoidance of Genotoxic
Intermediates/Impurities Tenable for Complex, Multi-Step
Syntheses? Org. Proc. Res. Dev., 19, 1437-1446.
3. ICH Q3A(R2). (2006) Impurities in New Drug Substances. Current
Step 4 version dated 25 October 2006.
4. ICH Q6A (1999) Specifications: Test procedures and acceptance
criteria for new drug substances and drug products: Chemical
Substances. Current Step 4 version dated 6 October 1999.
5. ICH Q2(R1). (2005) Validation of analytical procedures: Text and
methodology. Current Step 4 version Parent Guideline dated 27
October 1994 (Complementary Guideline on Methodology dated 6
November 1996 incorporated in November 2005).
6. ICH M7. (2014) Assessment and control of DNA reactive (mutagenic)
impurities in pharmaceuticals to limit the potential carcinogenic
risk. Current step 4 version, dated 23 June 2014.
7. ICH Q3B(R2) (2006) Impurities in New Drug Products. Current Step 4
version dated 2 June 2006.
8. Amitriptyline dosage: Usual adult dose for depression. Drugs.com.
https://www.drugs.com/dosage/amitriptyline.html#Usual_Adult_
Dose_for_Depression. Accessed on 19 March 2017.
9. Stevens W. (2009) Expectations for data to support clinical trial
drugs. APEC Advanced Workshop on Review of Drug Development
in Clinical Trials, Feb 2-6 2009, Bangkok, Thailand. http://www.
ich.org/fileadmin/Public_Web_Site/Training/GCG_-_Endorsed_
Training_Events/Advanced_workshop__Rev_of_Drug_Dev_in_CT/
Day_2/16-_Quality_Expectations_CT_Drugs.pdf. Accessed on 19
March 2017.
10. Bayliss MK, Butler J, Feldman PL, Green DV, Leeson PD, Palovich MR,
Taylor AJ. (2016) Quality guidelines for oral drug candidates: dose,
solubility and lipophilicity. Drug Disc. Today, 21(10), 1719-1727.
11. ICH M3(R2). (2009) Nonclinical Safety Studies for the Conduct
of Human Clinical Trials and Marketing Authorization for
Pharmaceuticals. Current step 4 version dated 11 June 2009.
12. ICH Q3C(R6). (2006) Impurities: Guidelines for residual solvents.
Current Step 4 version dated October 20, 2006.
13. ICH Q9. (2005) Quality risk management. Current Step 4 version
dated 9 November 2005.
16. Waterman KC, Adami RC, Alsante KM, Hong J, Landis MS, Lombardo
F, Roberts CJ. (2002) Stabilization of pharmaceuticals to oxidative
degradation. Pharm. Dev. Technol. 7(1); 1-32.
17. Li G, Schoneker D, Ulman KL, Sturm JJ, Thackery LM, Kauffman JF.
(2015) Elemental Impurities in Pharmaceutical Excipients. J. Pharm.
Sci., 104(12); 4197-4206.
18. ICH M7(R1). (2015) Addendum to ICH M7: Assessment and control
of DNA reactive (mutagenic) impurities in pharmaceuticals to limit
the potential carcinogenic risk. Application of the principles of the
ICH M7 guideline to calculation of compound-specific acceptable
intakes. Current Step 2 version dated 9 June 2015.
19. Teasdale A, Elder D, Chang S-J, Wang S, Thompson R, Benz N,
Sanchez Flores IH. (2013) Risk assessment of genotoxic impurities in
new chemical entities: Strategies to demonstrate control. Org. Proc.
Res. Dev., 17; 221-230.
20. Gaylor DW. (2000) The use of Haber's Law in standard setting and
risk assessment. Toxicology 149(1); 17-19.
21. Elder DP. (2014) Foreword: ICH M7: Mutagenic impurities: A critical
evaluation, Eur. Pharm. Rev., 19(1), 6.
22. Jones PS, Jones D. (2012) New regulatory framework for cancer drug
development. Drug Disc. Today, 17(5-6); 227-231.
23. ICH S9. (2009) Nonclinical evaluation for anticancer pharmaceuticals.
Current Step 4 version dated 29 October 2009.
24. Harvey J, Fleetwood, A, Ogilvie R, Teasdale A, Wilcox P, Spanhaak
S. (2017) Management of organic impurities in small molecule
medicinal products: Deriving safe limits for use in early
development. Regul. Toxicol. Pharmacol., 84; 116-123.
25. Department of Health. (2013) The UK strategy for rare diseases.
https://www.gov.uk/government/uploads/system/uploads/
attachment_data/file/260562/UK_Strategy_for_Rare_Diseases.pdf.
Accessed on 16 February 2017.
36
https://www.drugs.com/dosage/amitriptyline.html#Usual_Adult_Dose_for_Depression https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/260562/UK_Strategy_for_Rare_Diseases.pdf
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