Safety Evaluation of Biotechnologically-derived Pharmaceuticals: Facilitating a Scientific Approach
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Published By Springer Netherlands

9780792387329, 9789401148764

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Designing a safety evaluation programme for gene therapy products: Recommendations and the way forward

Safety Evaluation of Biotechnologically-derived Pharmaceuticals: Facilitating a Scientific Approach ◽

10.1007/978-94-011-4876-4_15 ◽

1998 ◽

pp. 159-167

Author(s):

Peter Harris ◽

Anthony Dayan

Keyword(s):

Gene Therapy ◽

Safety Evaluation ◽

Evaluation Programme ◽

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Designing non-clinical safety evaluation programmes for gene therapy products: A personal view

Safety Evaluation of Biotechnologically-derived Pharmaceuticals: Facilitating a Scientific Approach ◽

10.1007/978-94-011-4876-4_10 ◽

1998 ◽

pp. 115-128

Author(s):

James Macdonald ◽

Richard Morrissey ◽

James Patrick

Keyword(s):

Gene Therapy ◽

Safety Evaluation ◽

Personal View ◽

Clinical Safety

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Company strategies for designing non-clinical safety evaluation programmes: Results of a CMR International survey

Safety Evaluation of Biotechnologically-derived Pharmaceuticals: Facilitating a Scientific Approach ◽

10.1007/978-94-011-4876-4_3 ◽

1998 ◽

pp. 17-29

Author(s):

Susan A Griffiths

Keyword(s):

Safety Evaluation ◽

International Survey ◽

Clinical Safety

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Designing non-clinical safety evaluation programmes for monoclonal antibodies: Recommendations and the way forward

Safety Evaluation of Biotechnologically-derived Pharmaceuticals: Facilitating a Scientific Approach ◽

10.1007/978-94-011-4876-4_14 ◽

1998 ◽

pp. 151-157

Author(s):

James Green ◽

John Purves

Keyword(s):

Monoclonal Antibodies ◽

Safety Evaluation ◽

Clinical Safety ◽

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Designing non-clinical safety evaluation programmes for colony stimulating factors, growth factors and hormones: A personal view

Safety Evaluation of Biotechnologically-derived Pharmaceuticals: Facilitating a Scientific Approach ◽

10.1007/978-94-011-4876-4_7 ◽

1998 ◽

pp. 65-78

Author(s):

Douglas M Morton

Keyword(s):

Growth Factors ◽

Safety Evaluation ◽

Personal View ◽

Clinical Safety ◽

Colony Stimulating Factors

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Biotechnologically-derived Pharmaceuticals in Japan: Present and future prospects

Safety Evaluation of Biotechnologically-derived Pharmaceuticals: Facilitating a Scientific Approach ◽

10.1007/978-94-011-4876-4_6 ◽

1998 ◽

pp. 51-63

Author(s):

Tohru Inoue

Keyword(s):

Future Prospects

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Influence of regulatory systems: A viewpoint of the US FDA process

Safety Evaluation of Biotechnologically-derived Pharmaceuticals: Facilitating a Scientific Approach ◽

10.1007/978-94-011-4876-4_4 ◽

1998 ◽

pp. 31-38

Author(s):

Joy A Cavagnaro

Keyword(s):

Regulatory Systems ◽

The Us ◽

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Designing non-clinical safety evaluation programmes for interferons and interleukins: Past experiences and recommendations for future products

Safety Evaluation of Biotechnologically-derived Pharmaceuticals: Facilitating a Scientific Approach ◽

10.1007/978-94-011-4876-4_13 ◽

1998 ◽

pp. 139-149

Author(s):

Joy A. Cavagnaro ◽

Timothy Anderson

Keyword(s):

Safety Evaluation ◽

Clinical Safety ◽

Past Experiences

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Designing non-clinical safety evaluation programmes for colony stimulating factors, growth factors and hormones: Recommendations and the way forward

Safety Evaluation of Biotechnologically-derived Pharmaceuticals: Facilitating a Scientific Approach ◽

10.1007/978-94-011-4876-4_12 ◽

1998 ◽

pp. 133-138

Author(s):

Jennifer Sims ◽

Felix Iglesia

Keyword(s):

Growth Factors ◽

Safety Evaluation ◽

Clinical Safety ◽

Colony Stimulating Factors ◽

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Designing non-clinical safety evaluation programmes: The view of the clinician

Safety Evaluation of Biotechnologically-derived Pharmaceuticals: Facilitating a Scientific Approach ◽

10.1007/978-94-011-4876-4_1 ◽

1998 ◽

pp. 1-6

Author(s):

John Lipani

Keyword(s):

Safety Evaluation ◽

Clinical Safety

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