International Stability Testing
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19

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Published By CRC Press

9781003076087

Latest Documents Most Cited Documents Contributed Authors Related Sources Related Keywords

Stress Testing Programml: Drug Substance Characterization Studies

International Stability Testing ◽

10.1201/9781003076087-7 ◽

2020 ◽

pp. 91-106

Author(s):

Elisabeth Pacaud

Keyword(s):

Stress Testing ◽

Drug Substance ◽

Characterization Studies

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Photostability Testing

International Stability Testing ◽

10.1201/9781003076087-5 ◽

2020 ◽

pp. 59-71

Author(s):

Terry G. Beaumont

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Committee for Proprietary Medicinal Products: Reduced Stability Testing Plan Bracketing and Matrixing

International Stability Testing ◽

10.1201/9781003076087-10 ◽

2020 ◽

pp. 156-160

Author(s):

Per Heiboe

Keyword(s):

Stability Testing ◽

Medicinal Products ◽

Testing Plan

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Matrixing and Bracketing Designs for Stability Studies: An Overview from the European Perspective

International Stability Testing ◽

10.1201/9781003076087-9 ◽

2020 ◽

pp. 135-155

Author(s):

Per Heiboe

Keyword(s):

European Perspective ◽

Stability Studies

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Guideline for Industry 1

International Stability Testing ◽

10.1201/9781003076087-4 ◽

2020 ◽

pp. 49-58

Author(s):

David J. Mazzo

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Stability Testing Considerations for Some Non-ICH Areas

International Stability Testing ◽

10.1201/9781003076087-19 ◽

2020 ◽

pp. 315-324

Author(s):

Terry G. Beaumont

Keyword(s):

Stability Testing

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Postapproval FDA Stability Requirements

International Stability Testing ◽

10.1201/9781003076087-14 ◽

2020 ◽

pp. 235-254

Author(s):

Dhiren N. Shah

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Statistical and Regulatory Aspects of Drug Stability Studies: An FDA Perspective

International Stability Testing ◽

10.1201/9781003076087-8 ◽

2020 ◽

pp. 107-133

Author(s):

William R. Fairweather ◽

Tsae-Yun Daphne Lin

Keyword(s):

Drug Stability ◽

Stability Studies ◽

Regulatory Aspects

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The ICH Stability Guideline for Biological and Biotechnological Products

International Stability Testing ◽

10.1201/9781003076087-6 ◽

2020 ◽

pp. 73-89

Author(s):

Manfred Haase

Keyword(s):

Biotechnological Products

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Guideline for Industry 1

International Stability Testing ◽

10.1201/9781003076087-3 ◽

2020 ◽

pp. 42-46

Author(s):

David J. Mazzo

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