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Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, W
Solid Oral Dose Process Validation, Volume Two
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Authors: Ajay Pazhayattil
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The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lif
Developing Solid Oral Dosage Forms
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Authors: Yihong Qiu
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Type: BOOK - Published: 2009-03-10 - Publisher: Academic Press

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Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential pr
Validation of Pharmaceutical Processes
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Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of
Sample Preparation of Pharmaceutical Dosage Forms
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Authors: Beverly Nickerson
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This book is intended to serve as a resource for analysts in developing and troubleshooting sample preparation methods. These are critical activities in providi