By far the world's most definitive & authoritative
current ophthalmic drug development volume available.
"No development unit should be without it" - Pliva
We are sorry that this world
leader in ophthalmic R&D
development was not in print 15 years ago for our staff - ALCON
An amazing publication in absolute ophthalmic excellence
- Merck Co Inc NY USA
Compulsory reading for our
R&D, QA QC RA and formulation/prod units - Bausch & Lomb UK
Thank you for Vol 8, PI+PII absolutely
state-of-the art in every shape and form - Merck Sharp & Dohme
Our company purchased the entire 24 vol Handbook Series
and we find Vol 8 absolutely outstanding - it contains so much detail
- Pliva Pharma
By far the best R&D formulation book in our large library - Allergan
Your handbook taught us today's ophthalmic sterile technology - Novartis
Money very well spent on your ophthalmic Hand-book, thank you - UCB
A truly great publication - and a best seller, a flagship in your series-
LOCUM INT. PRESS
Vol, Edition # and Pub. Year.
H/B Vol 8/Ed 18 - 2018
H/B Vol 8/Ed 19 - 2019
H/B Vol 8/Ed 20 - 2020
H/B Vol 8/Ed 21 - 2021
H/B Vol 8/Ed 22 - 2022
H/B Vol 8/Ed 23 - 2023
H/B Vol 8/Ed 24 - 2024
New Updated Edition Annually.
Locum Publishers Clients
(Handbooks and Journals.
Handbook Generic Development
Sterile Eye and Nose Preparations
Two Part Development To Final Production Handbook
Locum International Press
(Complete Handbook in Two Parts)
of the 24 Volume Drug Development Series.
This lastest two part
authoritative Handbook of Pharmaceutical Generic Development is a practical
hands-on, technical research and development easily to read and understand
reference book packed with all the needed formula, specifications and
manufacturing procedures, batch-lot qualification, scale-up stages to
full sized batches with all current process specifications and validation
protocols and procedures covering the A-Z preparation steps for the creation
of profesional CTD/ANDA product sections for the manufacture of Sterile
Eye & Nose Preparations (ophthalmic drops, solutions and suspensions
and sterile nasal solutions, sprays and drops.)
Extensive coverage of sterile validation protocols from washing machines,
steam sterilizers and lyophilizers. Updated current advances and developments
in pharmaceutical, formulations, legal and regulatory product development
approaches by industry and agency experts that is needed to know and understand
for the development of these specialized sterile dosage forms.
Details advanced formula development and sterile process validation, including
validation protocols and checklists of all the major sterile cleaning
equipment and manufacturing processes, HVAC utilities and appropriate
sterilization procedures and equipment
Includes the required pharmaceutical legal and regulatory CTD/e-CTD/ANDA/EU/JAPAN
module development know-how providing essential development technology
on Sterile Eye & Sterile Nose Preparations
for professional top level developers to understand the nuts-and-bolts
on Sterile Generic Q1Q2 FDA mandated development in order to produce high-tech
detailed CTD/e-CTD/ANDAs. Explains in precise details the FDA/EU inactive
ingredient database (FDA-IID) on how to use this formulation database
in sterile Eye & Sterile Nose formulations/preparations.
Including key Tips and Traps to avoid. Highlights design and formulation
concepts using the innovator's RLD via simple reverse-engeneering procedures
and challenge tests.
Provides full production formulas and actual manufacturing process documentation
for both ophthalmic and nasal drops and solutions of top branded popular
commercial products such as Timolol, Naphazoline, Tetrahydrozoline (Visine),
Dorzolamide, Zylometazoline nasal drops and Flunisolide nasal solution.
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, Japan and Asian application files and dossiers. All IAGIM technology
is purposely and uniquely dove-tailed in regulatory drug product applications
-worldwide appliations made simple and precise. An extensively comprehensive
and authoritative handbook, reference work, formula, process research
and development manual of unparallel quality and state-of-the-art technical
Every document that goes into this CTD/e-CTD / ANDA / EU / JAPAN product
development system is explained in detailed, clear precise English with
FDA/EU prior-approved document examples on how to structure and layout
the key documentation - and what to include and what to omit.
Complete Volume in two parts 1990-2000 pp. Part
1 & 2 fully illustrated and annotated with diagrams, flow charts,
formula, graphs, spectra, side-by-side comparisons, tables in b/w &
color. Available in print (spiral soft cover opens flat) or via digital
CD (multi-users require additinal optional license). Split volume attract
a 25% handling and broken volume charge to split the two part volume.
Pharma Press are one of the world leading scientific R&D technical
publishers offering an exceptional range of peer reviewed journals, handbooks,
book databases and publishing services to the pharmaceutical science community.
We also offer a large and comprehensive range of product specific generic
handbooks to the pharmaceitical generic drug and innovative drug R&D
0793 7601 / 0793-761X
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