Biotechnology-derived products safety evaluation

Basic Principles for Preclinical Safety Evaluation of Cellular and Gene Therapies. For biotechnology-derived products in general... [Pg.66]

In 1997 the ICHS6 guidance on preclinical safety evaluation of biotechnology-derived products [2] introduced the concept of the case-by-case approach. This means that each new test article (product) or product class must have a science-based testing program custom prepared for that product... [Pg.1090]

S6 Preclinical Safety Evaluation of Biotechnology-Derived Products CPMP/ICH/302/95 Step 5... [Pg.762]

S5A S5B (M) S6 Reproductive Toxicology Detection of Toxicity to Reproduction for Medicinal Products Reproductive Toxicology Toxicity on Male Fertility (Modification) Preclinical Safety Evaluation of Biotechnology-Derived Products CPMP/ICH/386/95 CPMP/ICH/136/95 CPMP/ICH/302/95 Step 5 Step 5 Step 5... [Pg.768]

ICH/S6 - Preclinical Safety Evaluation of Biotechnology-derived Products... [Pg.768]

Biotechnologically-derived products are associated with unique but inherent safety issues which are specifically related to long-term pharmacological effects. Short-term preclinical trials may not adequately address these issues. In this chapter, the treatment of auto-immune disease is used to illustrate some of the problems encountered in the preclinical safety evaluation of biotechnologically-derived products. [Pg.5]

Examples of the safety evaluation documentation submitted as part of marketing applications for biotechnologically-derived products... [Pg.45]

Some of the problems in the safety evaluation of biotechnologically-derived products are ... [Pg.53]

The ICH guideline on preclinical safety evaluation of biotechnologically-derived pharmaceuticals has recently achieved Step 4 of the ICH process. This represents a success for harmonisation and it will be important to assess the impact of these guidelines on the development of biotechnology-derived pharmaceuticals. However, it will be necessary to continue to re-examine what new data may be necessary to assess the safety of biotechnologically-derived products and to identify new issues that need to be addressed. The CMR International workshop has made a significant contribution along these lines. [Pg.213]

Vital Safety Evaluation of Biotechnology Products Derived from CeU Liaes of Human or Animal Origin," ICH Harmonized Tripartite Guideline,... [Pg.145]

Quality of biotechnological products. Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin... [Pg.76]

International Conference on Harmonization. Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Eluman or Animal Origin, CR, 1997. [Pg.358]

ICH (2009) Draft consensus guideline. Addendum to ICH S6 precUnical safety evaluation of biotechnology-derived pharmaceuticals, http //www.ich. org/fileadmin/Public Web Site/ICH Products / Guidelines/Safety/S6 ... [Pg.89]

Committee for Proprietary Medicinal Products Note for Guidance on Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals. Human Medicines Evaluation Unit, The European Agency for the Evaluation of Medicinal Products, London (1997). [Pg.207]

ICH (1997), CPMP. Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin, Geneva. Available at http //www.ich.org/ LOB/media/MEDIA425.pdf (accessed October 2006). [Pg.370]

Onions D (1997), Safety evaluation of products derived from mammalian cell lines, In Flauser FI, Wagner R (Eds), Mammalian Cell Biotechnology in Protein Production, Walter de Gruyter, Berlin, pp. 171-190. [Pg.371]

Several years ago an ICH guidance (ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals) was written to address the preclinical development and safety issues of products derived from biotechnology. ICH S6 defined biotechnology-derived pharmaceuticals as products derived... [Pg.111]