Table 2.

Key guidelines relevant to non-clinical safety testing of mAbs

Guideline title	Authority	Year	Ref.
Preclinical Safety and Immunotoxicity Testing
• ICH guideline M3 (R2): Nonclinical safety studies for the conduct of human clinical trials with pharmaceuticals. Step 4.	EMA/FDA/Japan	2009	37
• ICH guideline S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.	EMA/FDA/Japan	1998	38
• ICHS6: Addendum Step 2.	EMA/FDA/Japan	2009	39
• Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use.	FDA	1997	40
• ICH guideline S8: Notes for Guidance on Immunotoxicity Testing of Human Pharmaceuticals.	EMA/FDA/Japan	2006	41
• FDA (CDER): Immunotoxicology Evaluation of Investigational New Drugs	FDA	2002	42
• Japanese MHLW/JPMA Draft Guidance for Immunotoxicity Testing	Japan	2001	43
• Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic proteins (draft)	EMA	2007	44
First-in-man dosing and MABEL
• Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers	FDA/CDER	2005	10
• Guideline on Strategies to Identify and Mitigate Risks for First-In-Human Clinical Trials with Investigational Medicinal Products	EMA/CHMP	2007	11