| Handbook
of Pharmaceutical Generic Development |
Part
I
|
Part II
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| Vol.
1 - Oral Tablets - Immediate Release (Part I + II)
- Ed. 01 + 01E |
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| Vol.
2 - Oral Capsules - Immediate Release (Part I + II)
- Ed. 02 + 02E |
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| Vol.
3 - Semisolids - Topical (Part I + II) |
|
|
| Vol.
4 - Oral IR Liquids (Part I + II) |
|
|
| Vol.
5 - Soft Gelatin Capsules (Part I + II) - Ed.
05 + 05E |
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| Vol.
6 - e-SOPs - Generic Development (Part I + II + III) |
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| Vol.
7 - Oral Suspensions including Reconstituted forms
(Part I + II) |
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| Vol.
8 - Sterile Eye Preparations (Part I + II) - Ed.
08 + 08E |
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| Vol.
9 - Generic Assay Methods and Validation (Stability
Indicating) (Part I + II) |
|
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| Vol.
10 - Oral Tablets - Controlled Release / MR (Part
I + II) - Ed. 10 + 10E |
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| Vol.
11 - Oral Capsules - Extended Release / SR (Part
I + II) - Ed. 11 + 11E |
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|
| Vol.
12 - Oral Tablets-Delayed Release (Enteric
Coated) (Part I + II) |
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| Vol.
13 - Generic Assay Methods (Stability Indicating)
(Part III + IV) |
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| Vol.
14 - Oral Tablets Combo MR+ IR+CR+DR+Chew Development
(Part I - 4) |
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| Vol.
15 - Oral Capsules Combo IR+ER/SR+MR+SGC Development
(Part I - 4) |
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|
| Vol.
16 - Oral Tablets IR+CR+DR+ Expert
Report + Development Report (Part I
- 4) |
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|
| Vol.
17 - Master Formula & Manufacturing Processes Vol
1 to 5 (Parts I -5) |
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| Vol.
18 - Master Formula & Manufacturing Processes Vol
6 to 10 (Part 6 - 10) |
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| Vol.
19 - eSOPs and PAI Checklists (Part I + II + III) |
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| Vol.
20 - Sterile Injections (IM/IV) (Part I + II) - Ed.
20 + 20E |
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| Vol.
21 - Oral Chew Tablets - Immediate Release (Part
I + II) - Ed. 21 + 21E |
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| Vol.
22 - Analytical Validation, Protocols, Procedures
& Results (Part 1 + 2) |
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Vol. 23 - Analytical Validation, Protocols, Procedures
& Results (Part 3 + 4) |
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| Vol.
24 - Validation Protocols/Procedures-IQOQ/Cleaning/Process
(Part 1 to 4) |
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Frequently
Asked Questions
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