| Handbook
of Pharmaceutical Generic Development |
Part
I
|
Part II
|
| Vol.
1 - Oral Tablets - Immediate Release (Part I + II)
- Ed. 01 + 01E |
|
|
| Vol.
2 - Oral Capsules - Immediate Release (Part I + II)
- Ed. 02 + 02E |
|
|
| 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 |
|
|
| Vol.
6 - e-SOPs - Generic Development (Part I + II + III) |
|
|
| Vol.
7 - Oral Suspensions including Reconstituted forms
(Part I + II) |
|
|
| Vol.
8 - Sterile Eye Preparations (Part I + II) - Ed.
08 + 08E |
|
|
| Vol.
9 - Generic Assay Methods and Validation (Stability
Indicating) (Part I + II) |
|
|
| Vol.
10 - Oral Tablets - Controlled Release / MR (Part
I + II) - Ed. 10 + 10E |
|
|
| Vol.
11 - Oral Capsules - Extended Release / SR (Part
I + II) - Ed. 11 + 11E |
|
|
| Vol.
12 - Oral Tablets-Delayed Release (Enteric
Coated) (Part I + II) |
|
|
| Vol.
13 - Generic Assay Methods (Stability Indicating)
(Part III + IV) |
|
|
| Vol.
14 - Oral Tablets Combo MR+ IR+CR+DR+Chew Development
(Part I - 4) |
|
|
| Vol.
15 - Oral Capsules Combo IR+ER/SR+MR+SGC Development
(Part I - 4) |
|
|
| Vol.
16 - Oral Tablets IR+CR+DR+ Expert
Report + Development Report (Part I
- 4) |
|
|
| Vol.
17 - Master Formula & Manufacturing Processes Vol
1 to 5 (Parts I -5) |
|
|
| Vol.
18 - Master Formula & Manufacturing Processes Vol
6 to 10 (Part 6 - 10) |
|
|
| Vol.
19 - eSOPs and PAI Checklists (Part I + II + III) |
|
|
| Vol.
20 - Sterile Injections (IM/IV) (Part I + II)
- Ed. 20 + 20E |
|
|
| Vol.
21 - Oral Chew Tablets - Immediate Release (Part
I + II)
- Ed. 21 + 21E |
|
|
| Vol.
22 - Analytical Validation, Protocols, Procedures
& Results (Part 1 + 2) |
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|
Vol. 23 - Analytical Validation, Protocols, Procedures
& Results (Part 3 + 4) |
|
|
| Vol.
24 - Validation Protocols/Procedures-IQOQ/Cleaning/Process
(Part 1 to 4) |
|
|
|
Frequently
Asked Questions
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|
|
|
1. Membership-CDs only available to IAGIM members of two
years (Parts I to IV)
2. All Handbooks come in the following print and electronic
editions licensed or unlicenced with quite different price
structures.
1. Print Volume PI and PII - Vol 05-P
2. Print Volume Advanced Edition PI and
PII - Vol 05E-PA
Read only Licences via CD or ONLINE DROP BOX
3. Electronic Standard Edition PI and
PII - Vol e-05 - READ ONLY)
4. Electronic Standard Edition PI and
PII - Vol e-05-RO-L10 / L25 /L50 - READ ONLY)
READ ONLY Licences for 10, 20
or 50+ readers
5. Electronic Advanced Edition PI and
PII - Vol e-05E-ARO-L10 (READ ONLY)
6. Electronic Advanced Edition PI and
PII - Vol e-05E-ARO-L25 (READ ONLY)
7. Electronic Advanced Edition PI and
PII - Vol e-05E-ARO-L50 (READ ONLY)
READ & PRINT Licences for 10, 20 or 50+ readers
7. Electronic Advanced Edition PI and
PII - Vol e-05E-APE-L10 (Licensed+Printable)
8. Electronic Advanced Edition PI and
PII - Vol e-05E-APE- L25 (Licensed+Printable)
9. Electronic Advanced Edition PI and
PII - Vol e-05E-APE- L50 (Licensed+Printable)
10. PRINT+Elect Advanced Edition PI &
PII - Vol e-05E-AP+E/E- L10 / L25 / L50 (Licensed+Printable)
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