DNA as a Pharmaceutical -Regulatory Aspects

DNA-Pharmaceuticals: Formulation and Delivery in Gene Therapy, DNA Vaccination and Immunotherapy

Volumn , Issue , 2006, Pages 7-21

  Kneuer, Carsten ^a  

^a UNIVERSITY OF LEIPZIG   (Germany)

Author keywords

Biosafety issues; Clinical trials; Comparability of plasmid gene therapy products; DNA gene therapy product; DNA pharmaceuticals; Environmental risk assessment; Quality requirements; Regulatory aspects; Safety studies

Indexed keywords

EID: 78651290333     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/3527607536.ch2     Document Type: Chapter

References (21)

1. Website of The Journal of Gene Medicine, www.wiley.co.uk/genmed/clinical.
2. The Genetic Modification Clinical Research Information System (GeMCRIS) of the NIH Office of Biotechnology Activities, www4.od.nih.gov/oba/RAC/GeMCRIS/GeMCRIS.htm.
3. CPMP/BWP/3088/99 Note for Guidance: Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products, April 24, 2001.
4. FDA Guideline: Guidance for Industry-FDA Guidance for Human Somatic Cell Therapy and Gene Therapy, March 30, 1998.
5. Office of Vaccines Research and Review: Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications, CBER (301) 594-2090, 1996.
6. Revision 3 of draft EMEA/410/01 Guideline: Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products, June 23, 2004.
7. ICH Harmonised Tripartite Guideline (Q3C), adopted as CPMP/ICH/283/ 95: Impurities: Residual Solvents, July 17, 1997.
8. FDA Guideline: Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals, July 12, 1993.
9. ICH Harmonised Tripartite Guideline, adopted as CPMP/ICH/294/95: Quality of Biotechnological Products: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products, July 16, 1997.
10. FDA Guideline: Guideline on validation of the limulus amebocyte lysate test as an end-product endotoxin test for human and animal parenteral drugs, biological products, and medical devices, December 2, 1987.
11. ICH Harmonised Tripartite Guideline (E8), adopted as CPMP/ICH/291/95: General Considerations for Clinical Trials, July 17, 1997.
12. ICH Harmonised Tripartite Guideline (E6), adopted as CPMP/ICH/135/95: The Guideline on Good Clinical Practice, July 17, 1996.
13. ICH Harmonised Tripartite Guideline (M3) adopted as CPMP/ICH/286/95: Non-clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, November 16, 2000. 21
14. ICH Harmonised Tripartite Guideline (S6), adopted as CPMP/ICH/302/95: Pre-Clinical Safety Evaluation of Biotechnology Derived Pharmaceuticals, July 16, 1997.
15. Draft guideline CPMP/SWP/112/98: Safety studies for Gene Therapy Products, January 28, 1998.
16. Draft FDA Guideline: Guidance for Industry and Reviewers-Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers, January 16, 2003.
17. FDA Biological Response Modifiers Advisory Committee (BRMAC) meeting report, May 10, 2002.
18. EMEA/CPMP/1978/04 Document: CPMP Gene Therapy Expert Group (GTEG) meeting report, February 26-27, 2004.
19. CVMP/IWP/07/98 Note for Guidance: DNA Vaccines Non-amplifiable in Eukaryotic Cells for Veterinary Use, March, 2000.
20. FDA: Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products, Federal Register, April 26, 1996 (61 FR 10426).
21. CPMP/3097/02 Note for Guidance: Comparability of Medicinal Products containing Biotechnology-derived Proteins as Drug Substance-Non Clinical and Clinical Issues, December 17, 2003.