Professional Documents
Culture Documents
TE
RI
AL
ix xi xv
ED
PART I
INTRODUCTION
MA
1 3
HT
David J. am Ende
21
PY R
IG
29
57
CO
67
PART II 6
71 73
79
vi
CONTENTS
101
113
10
137
11
155
12
183
13
213
14
249
15
269
16
299
17
315
18
347
19
365
20
379
21
407
22
417
23
Process Development and Case Studies of Continuous Reactor Systems for Production of API and Pharmaceutical Intermediates
Thomas L. LaPorte, Chenchi Wang, and G. Scott Jones
437
24
457
CONTENTS
vii
25
477
26
491
27
505
28
The Role of Simulation and Scheduling Tools in the Development and Manufacturing of Active Pharmaceutical Ingredients
Demetri Petrides, Alexandros Koulouris, Charles Siletti, Jos O. Jimnez, and Pericles T. Lagonikos e e
521
PART III 29
543 545
30
563
31
581
32
597
33
621
PART IV 34
DRUG PRODUCTS
633 635
Process Modeling Techniques and Applications for Solid Oral Drug Products
Mary T. am Ende, Rahul Bharadwaj, Salvador Garca-Munoz, William Ketterhagen, Andrew Prpich, and Pankaj Doshi
35
663
36
673
37
Controlled Release Technology and Design of Oral Controlled Release Dosage Forms
Avinash G. Thombre, Mary T. am Ende, and Xiao Yu (Shirley) Wu
703
38
727
39
757
viii
CONTENTS
40
781
41
The Freeze-Drying Process: The Use of Mathematical Modeling in Process Design, Understanding, and Scale-Up
Venkat Koganti, Sumit Luthra, and Michael J. Pikal
801
42
Achieving a Hot Melt Extrusion Design Space for the Production of Solid Solutions
Luke Schenck, Gregory M. Troup, Mike Lowinger, Li Li, and Craig McKelvey
819
43
837
44
Pharmaceutical Manufacturing: The Role of Multivariate Analysis in Design Space, Control Strategy, Process Understanding, Troubleshooting, and Optimization
Theodora Kourti
853
INDEX
879