Handbook Generic Development
Oral Capsules -
(All Dosage Forms)
Two Part Development To Final Production Handbook
Locum International Press.
15 - (IR, ER, SR, SGC)
24 Volume Drug Development Series.
Availability Print - (Four Dosage forms)
This Handbook of Pharmaceutical Drug Development is a practical hand-on
workbook covering all aspects of drug development in four types of single
dose oral capsules for both immediate and
Covers pharmaceutical drug development by providing hands-on easy-to-understand
current know-how for the development, formulation, dissolution, scale-up,
process optimization and qualification; stability, pivotal (bio) and final
validation batch lots.
Includes analytical, cleaning and process validation, critical and essential
documentation peppered with legal and regulatory know-how that is essential
for a first time successful review for a FDA approval, saving queue-time
and lost market sales.
An Essential Reference for Development Pharmacists, R&D Chemists, QA/QC
and Regulatory personnel. Each and every document, protocol and procedure
in Part I + II is expertly referenced to the appropriate module number
in the CTD / e-CTD system thus providing a fully seamless and effortless
integration into either US, EU and Asian application files and dossier.
All IAGIM technology is purposely and uniquely dove-tailed in regulatory
drug product applications -worldwide applications made simple and precise.
Essential development and submission know-how on immediate and extended
release oral capsules for the professional
drug developer to really understand the nuts-and-bolts of capsule drug
development with a high-tech integrated formulation charts, unique and
advanced developmental procedures, flowcharts, decision trees, tables,
development SOPs, checklists and much more.
Volume ~1800 pp for Part 1 to 4 fully
with diagrams, graphs, tables in b/w & color as
a complete volume in four parts.
| Handbook Series | Journal
Index | Specialized Journals