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