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International Journal
of
Generic Drugs
ISSN 0793-694X
JOURNAL SUBSCRIBERS
International .Journal of :
Generic
Drugs
Drug Development
Drug
R&D
Drug Formulation
Generic
Formula & Processes
Drug cGMP
Drug Process
Validation
Generic
Registration
Editorial
Journal TOC
Information
Call for Papers
Vol.1 1998
Vol.2 1999
Vol.3 2000
Vol.4 2001
Vol.5 2002
Vol.6 2003
Vol.7 2004
Vol.8 2005
Vol.9 2006
Vol.10 2007
Vol.11 2008
Vol.12 2009
Vol.13 2010/2011
Vol.14 2012/2013
Vol.15 2014/2015
Editorial Board
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Table of Contents
Representive Sampling
Current Journal Issues
| Material Selection |
Choosing the Right Active
Choosing the Right Excipient
Choosing the Right Dyes and Colors
DMF's Do's and Don'ts
The Development Notebook |
| Generic Drug Manufacture |
Preparing the Right Documentation
Manufacturing Instructions Dos and Donts
Developing the Formula from A - Z
Developing CR / MR/ ER and DR Forms
Development Checklist Step-by-Step.
Individual and Population Bioequivalence
Bioequivalence and IVIVC, & CDP's |
| Setting the Correct Specifications |
In-process, Release and Check
Specifications
Decision Trees (Polymorphism, Impurities etc.)
10 Key Decision Trees Presented as SOPs |
| Process Validation and Protocols |
Scale-up for Specific Dosage
Forms
Cleaning Validation Requirements
PAIs and Post-approval Inspections
Tablet Hardness Qualification / LOD
Sampling and Testing the Pivotal Batch |
| Container-Closure Systems |
Closure DMF's - Vendors Obligations
ANDA Container-Closure Requirements
EC and ANDA comparisons
Getting the paper work right-first time
New guidelines / New DMF obligations
USP / 21 CFR / Indirect Food Regulations |
| Quality Control and Assurance |
Audits and Vendor Inspections
Vendor Audits by Mail/Fax
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| Microbiological Controls |
Purified Water USP - when to
use it
Topicals and their controls
Cleaning Limits |
| Pharmaceutical Stability |
Auditing your Stability Department
Time limitations in the stability protocols
Checking the Reference Listed Drug
Reduced Testing Plans - Bracketing / Matrixing |
| Analytical Aspects |
Auditing Raw Data / Impurities
/ Limits
Handling graphs and print-outs
High Speed stability assay validations
Model validation protocols /Assay /Dissolution
Residual Solvents, OVI's & Limits/Regulations
Ruggedness and Robustness / FDA vs.ICH |
| Auditing Your firm |
Spotting Deficiencies before
PAI inspections
Building in success for PAIs & File Reviews |
| Regulatory Affairs |
ANDA & Global Generic Development
Global Product Registration made Simple
ANDA Templates for any Documentation system
All ANDA's made Simple / EU interfacing |
| Regulatory Do’s and Don’ts
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Tips and Traps to Consider
Annual Reports made Simple |
| Bulk Pharmaceutical Chemicals |
Actives for Generic Drugs
Drug Master Files - Actives
How and what to validate |
| New Regulations |
| How to handle New OGD's Regulations.
OGD regulations made Simple Converting FDA speak into English
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| Current Checklists |
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Generic Development Checklists
Analytical checklists
Stability system checklists
PAI Approvals - All that's necessary
Drug Development Checklists - Tablets (IR + MR/CR +DR)
Drug Development Checklists - Capsules (IR + MR/ER)
Drug Development Checklists - Capsules (Soft Gelatin)
Drug Development Checklists - Semisolids
Drug Development Checklists - Suspensions / Liquids
Drug Development Checklists - Eye&Nose Preparations
Drug Development Checklists - Sterile Injections
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| SOPs of the Month |
New SOPs for generic firms
Six Major Decision Trees
Current SOPs you should have
SOPs for your firms security. |
| Regulatory and Patents Info |
The Generic Drug Enforcement
Act
Seminar Summaries /Conferences.
Drugs Off-Patents to the year 2017
Drugs coming Off-Patent (annually)
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