Pharmaceutical Process Scale-Up
Fourteen papers detail the theory and practice underlying the transfer of pharmaceutical processes from laboratory scale to the pilot plant, and eventually to production scale. Spotlighting proven methods of batch enlargement, the book uses a dimensional analysis to quantify similar processes on different scales. Regulatory requirements for scale-up and post-approval changes are emphasized. Appendices provide guidelines for industry. Annotation c. Book News, Inc., Portland, OR (booknews.com)
1004888495
Pharmaceutical Process Scale-Up
Fourteen papers detail the theory and practice underlying the transfer of pharmaceutical processes from laboratory scale to the pilot plant, and eventually to production scale. Spotlighting proven methods of batch enlargement, the book uses a dimensional analysis to quantify similar processes on different scales. Regulatory requirements for scale-up and post-approval changes are emphasized. Appendices provide guidelines for industry. Annotation c. Book News, Inc., Portland, OR (booknews.com)
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Pharmaceutical Process Scale-Up

Pharmaceutical Process Scale-Up

Pharmaceutical Process Scale-Up

Pharmaceutical Process Scale-Up

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Overview

Fourteen papers detail the theory and practice underlying the transfer of pharmaceutical processes from laboratory scale to the pilot plant, and eventually to production scale. Spotlighting proven methods of batch enlargement, the book uses a dimensional analysis to quantify similar processes on different scales. Regulatory requirements for scale-up and post-approval changes are emphasized. Appendices provide guidelines for industry. Annotation c. Book News, Inc., Portland, OR (booknews.com)

Product Details

ISBN-13: 9781032918990
Publisher: CRC Press
Publication date: 10/14/2024
Series: Drugs and the Pharmaceutical Sciences
Edition description: 3rd ed.
Pages: 548
Product dimensions: 6.00(w) x 9.00(h) x (d)

About the Author

Levin, Michael

Table of Contents

Prefacev
Introductionvii
Contributorsxv
1.Dimensional Analysis and Scale-Up in Theory and Industrial Application1
2.Parenteral Drug Scale-Up43
3.Nonparenteral Liquids and Semisolids57
4.Scale-Up Considerations for Biotechnology-Derived Products95
5 (1).Batch Size Increase in Dry Blending and Mixing115
5 (2).Powder Handling133
6.Scale-Up in the Field of Granulation and Drying151
7.Batch Size Increase in Fluid Bed Granulation171
8 (1).Scale-Up of the Compaction and Tableting Process221
8 (2).Practical Aspects of Tableting Scale-Up239
8 (3).Dimensional Analysis of the Tableting Process253
9.Scale-Up of Film Coating259
10.Engineering Aspects of Process Scale-Up and Pilot Plant Design311
11.A Collaborative Search for Efficient Methods of Ensuring Unchanged Product Quality and Performance During Scale-Up of Immediate-Release Solid Oral Dosage Forms325
AppendixesGuidance for Industry
A.Immediate Release Solid Oral Dosage Forms--Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation353
B.SUPAC-MR: Modified Release Solid Oral Dosage Forms--Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation373
C.SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms--Manufacturing Equipment Addendum415
D.Extended Release Oral Dosage Forms--Development, Evaluation, and Application of In Vitro/In Vivo Correlations447
E.Nonsterile Semisolid Dosage Forms--Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation SUPAC-SS469
F.SUPAC-SS: Nonsterile Semisolid Dosage Forms--Manufacturing Equipment Addendum499
G.Changes to an Approved NDA or ANDA517
H.Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System551
Index565
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