/
northeastbiolab
Follow Us On LinkedIn
sales@nebiolab.com
Follow Up On Email
Agile Bioanalytical Services CRO
Request Quote
✕
Expertise
All Expertise
Mass Spectrometry (LC-MS)
Mass Spectrometry Services
HPLC Testing Services
Meso Scale Discovery Assay
ELISA Assay
Luminex Multiplex Assay
qPCR Analysis, ddPCR Assay
Western Blot, In Cell Western
Services
All Services
Pharmacokinetics (PK) Study
Toxicology (Tox) Study
Dose Formulation Analysis
PK PD Analysis
Drug Metabolism and Pharmacokinetics (DMPK)
ADME Studies
Bioequivalence and Bioavailability Studies
ADA Assay, Neutralizing Antibody Assay
Cytokine Analysis, Biomarker Assay
Biomarker Assay List
Cell-Based Assays
Mechanism of Action (MOA) Studies
Cytotoxicity Assay
Biochemical Assay
Bioanalytical Assay Validation
Solutions
All Solutions
Clinical CRO
Central Lab Services
GLP Laboratory
Bioanalysis
Non-GLP Testing
Preclinical CRO
Method Development, Validation, And Transfer
Method Validation
Method Development
Method Transfer
Analytical Testing
Discovery and Research
Analytical Quantitation
Cosmetic Testing
About Us
About Us
Overview
Leadership
Facility and Equipment
Quality and Compliance
Therapeutic Areas
Why Us?
Values
Process
Partners
Careers
Business Development Associate
Sr. Scientist – Cell Based Assay
GLP Quality Assurance Manager
Sr. Scientist, ELISA Immunoassay Bioanalysis
Sr. Scientist, LC-MS/MS Bioanalysis
Associate Scientist, Central Laboratory Services
Sr. Scientist - Pharmacokinetics (PK)
Content Manager, Scientific and Regulatory Writing
Resources
Learning Center
Blog
Case Study
Video Brochures
News and Events
Testimonials
Contact Us
Request Quote
Contact Us
Home
FDA Preclinical Safety Evaluation of Biotechnology Derived Pharmaceuticals (2009)
FDA S6 (R1) Addendum: Preclinical Safety Evaluation of Biotechnology – Derived Pharmaceuticals (2009)
Retrieved From
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/s6-r1-addendum-preclinical-safety-evaluation-biotechnology-derived-pharmaceuticals