Specification of Drug Substances and Products
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9780081028247
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Dissolution

2020 ◽  
pp. 481-503
Author(s):  
Vivian A. Gray ◽  
Thomas W. Rosanske

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

2020 ◽  
pp. 59-99
Author(s):  
David K. Lloyd ◽  
James Bergum ◽  
Qinggang Wang
Keyword(s):  
Analytical Methods ◽  
Quality By Design ◽  
Development And Validation

Biotechnology products: validation of analytical methods

2020 ◽  
pp. 587-603
Author(s):  
Jennifer E. Dally ◽  
Myrna A. Monck
Keyword(s):  
Analytical Methods ◽  
Biotechnology Products

Description and identification

2020 ◽  
pp. 177-194
Author(s):  
Ernest Parente

Pharmacopeial methods and tests

2020 ◽  
pp. 607-637
Author(s):  
Eric B. Sheinin

Residual solvents

2020 ◽  
pp. 345-365
Author(s):  
George L. Reid
Keyword(s):  
Residual Solvents

Elemental and inorganic impurities

2020 ◽  
pp. 367-392
Author(s):  
Ernest Parente

Analytical methods in the clinical phase of development

2020 ◽  
pp. 101-124
Author(s):  
John D. Orr ◽  
George L. Reid
Keyword(s):  
Analytical Methods ◽  
Clinical Phase
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