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IAGIM - Drug Development Association


IAGIM - Handbook Catalog - MAIN INDEX
(Generic & Innovative)

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)
Vol. 23 - Analytical Validation, Protocols, Procedures & Results (Part 3 + 4)
Vol. 24 - Validation Protocols/Procedures-IQOQ/Cleaning/Process (Part 1 to 4)
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