Specification of Drug Substances and Products
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Published By Elsevier

9780081028247

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Dissolution

Specification of Drug Substances and Products ◽

10.1016/b978-0-08-102824-7.00018-x ◽

2020 ◽

pp. 481-503

Author(s):

Vivian A. Gray ◽

Thomas W. Rosanske

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Application of quality by design to the development and validation of analytical methods

Specification of Drug Substances and Products ◽

10.1016/b978-0-08-102824-7.00004-x ◽

2020 ◽

pp. 59-99

Author(s):

David K. Lloyd ◽

James Bergum ◽

Qinggang Wang

Keyword(s):

Analytical Methods ◽

Quality By Design ◽

Development And Validation

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Biotechnology products: validation of analytical methods

Specification of Drug Substances and Products ◽

10.1016/b978-0-08-102824-7.00022-1 ◽

2020 ◽

pp. 587-603

Author(s):

Jennifer E. Dally ◽

Myrna A. Monck

Keyword(s):

Analytical Methods ◽

Biotechnology Products

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Residual solvents

Specification of Drug Substances and Products ◽

10.1016/b978-0-08-102824-7.00013-0 ◽

2020 ◽

pp. 345-365

Author(s):

George L. Reid

Keyword(s):

Residual Solvents

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Description and identification

Specification of Drug Substances and Products ◽

10.1016/b978-0-08-102824-7.00008-7 ◽

2020 ◽

pp. 177-194

Author(s):

Ernest Parente

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Pharmacopeial methods and tests

Specification of Drug Substances and Products ◽

10.1016/b978-0-08-102824-7.00023-3 ◽

2020 ◽

pp. 607-637

Author(s):

Eric B. Sheinin

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Elemental and inorganic impurities

Specification of Drug Substances and Products ◽

10.1016/b978-0-08-102824-7.00014-2 ◽

2020 ◽

pp. 367-392

Author(s):

Ernest Parente

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Front Matter

Specification of Drug Substances and Products ◽

10.1016/b978-0-08-102824-7.01001-0 ◽

2020 ◽

pp. iii

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Analytical methods in the clinical phase of development

Specification of Drug Substances and Products ◽

10.1016/b978-0-08-102824-7.00005-1 ◽

2020 ◽

pp. 101-124

Author(s):

John D. Orr ◽

George L. Reid

Keyword(s):

Analytical Methods ◽

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Process analytical technology

Specification of Drug Substances and Products ◽

10.1016/b978-0-08-102824-7.00007-5 ◽

2020 ◽

pp. 149-173

Author(s):

Ian Clegg

Keyword(s):

Process Analytical Technology ◽

Analytical Technology

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