All ABOUT Handbooks A UNIQUE DRUG DEVELOPMENT …

1 All ABOUTH andbooksA UNIQUE drug DEVELOPMENT SERIESA UNIQUE drug DEVELOPMENT SERIESFOR THEFOR THEDEVELOPMENTAL KNOW HOWDEVELOPMENTAL KNOW HOWOF THE WORLDS TOPOF THE WORLDS TOPGENERIC DRUGSGENERIC DRUGSDRUG DEVELOPMENTHand?20@&?0 2@BooksDrug DEVELOPMENT & Manufacture for Pharmaceutical Technology ProfessionsInternational Journal of Generic International Journal of Generic Drugs e-* 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific RimLocum InternationalLocum Publishing HouseThe International Association ofGeneric drug ManufacturersISSN 0793 7601 - ISSN 0793 761 XSeries Publication in association with.

2 -NEW EditionYear 2002 Part ONEDRUG DEVELOPMENT KNOW-HOW&Part TWOANDA DEVELOPMENT & FORMULATIONSH andbook Volume in Part I & IIDrug DevelopmentANDA DEVELOPMENTH andbook ofPharmaceutical GenericDevelopmentOral IRTabletsHandbook of Pharmaceutical GenericDevelopment a comprehensive andauthoritative practical hands-on state-of-the-art handbook covering Generic know-how essential for developing the 21 ANDAS ections of an Immediate Release One covers Pharmaceutical DrugDevelopment and Part Two (ANDAD evelopment) providing know-how forDevelopment, Excipient and specificationchoice, Formulation, Dissolution, Stability,Scale-up, Process Qualification (HardnessDissolution & U of C); Pivotal and finalvalidation batches; Analytical, Cleaning andProcess Validation.

3 Incorporates essentialdevelopment checklists, flowcharts,tabulations and key SOPs and criticaldocumentation and OGD regulatory know-how for a successful review for a FDAapproval, saving queue-time and DEVELOPMENT and submissionknow-how on Immediate Release OralTablets for professional developers tounderstand the nuts-and-bolts on GenericANDA DEVELOPMENT with high-techdetailed ANDA DEVELOPMENT (new formula &guidelines) for rapid flawless approval ofANDA submissions (Print or CD ROM).Some Additional Titles:-Bupropion, BuspIrone, Diclofenac, Famotidine,Felodipine, Nabumetone, Naproxin, Piroxicam,Tamoxifen US/EU, Ticlopidine, Trazodone : Int.

4 : + 972-97-494-532 Fax US: +(1)-435-408-1665 Fax UK: +(44)-207-900-2096A Locum House Publication - Copyright Locum 1996-2000 International Journal of Generic International Journalof Generic Drugse-* 0793 694X US/Canada ISSN 0793 7784 EuroISSN 0793 7822 Pacific RimORAL DOSAGE FORMST able of Content - SummaryPART I - PHARMACEUTICAL DEVELOPMENTT ypical - Oral Tablet or CapsuleAcronyms - AbbreviationsIntroduction, Preface & ForwardChapter 11 Regulatory - Pre-formulation ChecklistDocumentation- SOP Control ChecklistDevelopment Notebooks- DEVELOPMENT Notebooks Checklist- SOP Control and DEVELOPMENT Notebooks SOPsChapter 22 Developing the Formula -an Overview- Formulation Checklist- Key Generic DEVELOPMENT formulationsDrug DEVELOPMENT Checklist (Top Generics )

5 DEVELOPMENT Formula for today's top GenericsDeveloping the generic FormulaProduct DEVELOPMENT Flow ChartProduct DEVELOPMENT Guide - Tips & TrapsPurified Water - an essential ingredientDo and Don'ts in DEVELOPMENT Purified Water - ChecklistChapter 33 Active Ingredients-Do s and Don ts-Active DEVELOPMENT Checklist-Approved Suppliers Checklist-Standard Operating Procedures, ActivesChapter 44 Semi active ingredients-Validating the Semi-active ingredients, ChecklistQualifying the Antioxidant - Protocol & ProcedureAntioxidant Tabulations & DocumentationChapter 55 Non active materials (excipients)-Checklist non active ingredient & FDA IIG list-Standard Operating Procedures, Non activesChapter 66 Container closure systems-Container-liner-closure systems, Checklist-Container-liner-closure systems, Key SOPs-Packaging Components - rules & regulations-Packaging Components Documentation Requirements SOPC hapter 77 Manufacturing Process & Instructions from A to Z- Wet, Dry, Spray Granulation- Aqueous & alcoholic granulation- Dry Mixing and Slugging- Manufacturing Instructions.

6 Checklist- The manufacturing Instructions and Controls- Manufacturing Flow Charts and Diagrams- Large scale manufacturing Instructions- Large scale Master Formula and Processes -key generics- Large scale Manufacturing InstructionsChapter 88In-process Quality Controls-Manufacturing in-process controls; Checklist-In-process Quality Controls; SOPsChapter 99 Finished Product Specifications- Finished Product Specifications example and Checklist- Release & Check Specifications- Finished Product Specifications; Required SOPsChapter 1010 Qualification of Antioxidant and LubricantProcess Optimization and ProceduresQualification of Loss on Drying LimitsChapter 1111 Scale-up Procedures know-how- Scale-up procedures; checklist- Scale-up procedures; SOPsChapter 1212 Cleaning Procedures, guidelines & LimitsCleaning Limits Procedures; ChecklistCleaning Validation Requirements.

7 SOPsChapter 1313 Analytical Validation Requirements-Analytical Testing Out of Specification-Analytical Testing Do's and Don'ts-Ruggedness and Robustness -Impurities in drug Substances -Impurities Do's and Don'ts-Impurities Glossary of Terms-Impurities Decision TreesAnalytical Post approval Changes -PAC-ALTSPAC-ALTS ChecklistChapter 1414 Process Qualification Batch Know-how-Process Qualification Batch; Checklist-Process Qualification Batch; SOPs-Process Qualification Blend Analysis and - Do's and Don'ts-Process Qualification Content Uniformity or Tablet HardnessContent Uniformity or Tablet Hardness ProtocolChapter 1515 Pivotal batch Operation & Process from A to Z -The Pivotal Batch regulatory requirements-Pivotal batch Checklist & Do's and don'ts-Pivotal batch Critical SOPs, Tips & Traps-Sampling and Testing the Pivotal Batch-Auditing the Pivotal batch - Tablulations-Auditing the Pivotal batch - ChecklistChapter 1616 Bioequivalence vs.

8 RLD Test Designs - OverviewStatistical BioequivalenceIBE Equation explainedIBE Big Picture (Pros and Cons)Comparing IBE and ABET ypical IVIVC ModelsChoosing IVIVC levelsDissolution Testing in IR Dosage FormsSimilarity Factor in dissolution testing BSC and Biowaivers Overall Dissolution Picture Biopharmaceutics Classification System Performance Verification in Dissolution testingFood-Effects in BA-BE StudiesSimilarity Testing - Chow, Pitt and OthersChapter 1717 Technical Transfer Documentation-Technical Transfer Documentation; Checklist-Technical Transfer Documentation; Pharmaceutical Part-Technical Transfer Documentation; Analytical PartChapter 1818 The Process Validation Batch - Tips & Traps-The Process Validation Batches; Checklist-Process Validation Requirements.

9 SOPs-Process Validation Master Plan & ProtocolsChapter 1919 Pre--Approval InspectionsPAI SummaryPre--Approval Inspection Audit - Team Set UpPre--Approval Inspection Audit - Team ActivitiesChapter 2020 Stability Testing of drug Substance and drug Product IStability Testing of drug Substance and drug Product IIStability Testing of drug Substance and drug Product IIStability Testing Significant ChangeStorage ConditionsSetting up a functional Stability UnitStability SOPs DevelopmentChapter 2121 Standard Operational Procedures DEVELOPMENT SOPs ; Stability SOP NetworkIndex of Pharmaceutical Standard Operating ProceduresIndex of Analytical Standard Operating ProceduresIndex of Microbiological Standard Operating ProceduresIndex of Stability Standard Operating of Generic drug DEVELOPMENT - 24 Volume International JournalofGeneric Drugs e-* 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim handbook drug DEVELOPMENT SeriesISSN 0793 8772 - ISSN 0793 8780 ControlledReleaseExtended Solid Oral Dosage FormsPart ONEC omplete drug DEVELOPMENT Know-how&Part TWOANDA

10 Formula & DEVELOPMENT TechnologyCONTROLLED RELEASE TABLETS handbook ofPharmaceuticalGenericDevelopmentTablet sThis handbook of Pharmaceutical GenericDevelopment is a fully comprehensivepractical hands-on workbook covering moderndrug DEVELOPMENT and the full 21 ANDA section interactions of a Extended or ModifiedControlled Release Oral Tablets or One ( drug DEVELOPMENT ) and Part Two(ANDA DEVELOPMENT Know-how) provideDevelopment, Master drug Formulations, KeyProcesses, Scale-up; Process Optimization &Qualification; Stability; Pivotal and finalProcess Validation Know-how and Protocols;PAI, Analytical, Cleaning and ProcessValidation Do's & Don'ts.