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خانه » فروشگاه » Technical Project Management for Generic Drug Development

Technical Project Management for Generic Drug Development

سرفصل های دوره

Become a Technical Project Manager by Learning Generic Drug Development!


1 - Introduction
  • 1 - 1-Introduct-on.pdf
  • 1 - Introduction

    • 2 - Introduction to Generic Drug Development
  • 2 - 2-1-PM.pdf
  • 2 - Active Pharmaceutical Ingredient API Finished Pharmaceutical Product FPP
  • 3 - 2-2-PM.pdf
  • 3 - Reference Listed Drug RLD Generic Multisource Pharmaceutical Products
  • 4 - 2-3-PM.pdf
  • 4 - Pharmaceutical Bioequivalency Therapeutic Equivalency
  • 5 - 2-4-PM.pdf
  • 5 - Reference Listed Drug RLD Development
  • 6 - 2-5-PM.pdf
  • 6 - Generic Drug Development
  • 7 - 2-6-PM.pdf
  • 7 - Comparision of Reference Listed Drug RLD Development Generic Drug Developmen
  • 8 - 2-7-PM.pdf
  • 8 - Invitro Invivo Studies for Drug Product

    • 3 - Introduction to Project Management
  • 9 - 3-1-PM.pdf
  • 9 - Project Elements of Project Cost Time Scope
  • 10 - 3-2-PM.pdf
  • 10 - Priorizitation of Project Pipeline
  • 11 - 3-3-PM.pdf
  • 11 - Project Phases
  • 12 - 3-4-PM.pdf
  • 12 - Project Manager
  • 13 - Project Team Project Stakeholders
  • 14 - 3-6-PM.pdf
  • 14 - Project Management Tools

    • 4 - Project Management for Generic Drug Development
  • 15 - 4-1-PM.xlsx
  • 15 - Project Diary for Generic Drug Development
  • 16 - 4-2-PM.xlsx
  • 16 - Project Milestones for Generic Drug Development
  • 17 - 4-3-PM.xlsx
  • 17 - Project Gantt Chart for Generic Drug Development
  • 18 - 4-4-PM.xlsx
  • 18 - Generic Drug Development Project Phases

    • 5 - Desk Research for Generic Drug Development
  • 19 - 5-1-PM-DeskResearch.pdf
  • 19 - Desk Research for Generic Drug Development
  • 20 - 5-2-PM-DeskResearch.pdf
  • 20 - European Medicines Agency EMA
  • 21 - 5-3-1.pdf
  • 21 - 5-3-2.pdf
  • 21 - 5-3-PM-DeskResearch.pdf
  • 21 - World Health Organization WHO Food and Drug Administration FDA
  • 22 - 5-4-PM-DeskResearch.pdf
  • 22 - Pharmacopoeias Dailymed
  • 23 - 5-5-PM-DeskResearch.pdf
  • 23 - Drugscom
  • 24 - 5-6-PM-DeskResearch.pdf
  • 24 - DrugBank
  • 25 - 5-7-1.pdf
  • 25 - 5-7-PM-DeskResearch.pdf
  • 25 - Google Patents
  • 26 - 5-8-PM-DeskResearch.pdf
  • 26 - Espacenet

    • 6 - Raw Material Selection for Generic Drug Development
  • 27 - 6-1-PM-RawMaterialSelection.pdf
  • 27 - Raw Material Selection for Generic Drug Development
  • 28 - 6-2-PM-RawMaterialSelection.pdf
  • 28 - Evaluation of Characteristics of API
  • 29 - 6-3-PM-RawMaterialSelection.pdf
  • 29 - Stability Characteristics of API
  • 30 - 6-4-PM-RawMaterialSelection.pdf
  • 30 - Evaluation of Suppliers of API
  • 31 - 6-5-PM-RawMaterialSelection.pdf
  • 31 - Evaluation of Inactive Ingredient and Packaging Material

    • 7 - PreFormulation Studies for Generic Drug Development
  • 32 - 7-1-PM-PreFormulationStudies.pdf
  • 32 - PreFormulation Studies for Generic Drug Development
  • 33 - 7-2-PM-PreFormulationStudies.pdf
  • 33 - Characterization of RLD
  • 34 - 7-3-PM-PreFormulationStudies.pdf
  • 34 - Defining Quality Target Product Profile QTPP
  • 35 - 74
  • 35 - Evaluation of BE Requirements
  • 36 - 7-5-PM-PreFormulationStudies.pdf
  • 36 - Evaluation of Inactive Ingredient Required for Formula
  • 37 - 7-6-PM-PreFormulationStudies.pdf
  • 37 - Compatibility Study
  • 38 - 7-7-PM-PreFormulationStudies.pdf
  • 38 - Supplying New material Apparatus Equipment
  • 39 - 7-8-PM-PreFormulationStudies.pdf
  • 39 - Performing PreFormulation Trials

    • 8 - Analytical Method Development Studies for Generic Drug Development
  • 40 - 8-1-PM-AMD-Studies.pdf
  • 40 - Analytical Method Development Studies for Generic Drug Development 1
  • 41 - 8-2-PM-AMD-Studies.pdf
  • 41 - Analytical Method Development Studies for Generic Drug Development 2
  • 42 - 8-3-PM-AMD-Studies.pdf
  • 42 - Literature Search for Analytical Method Development
  • 43 - 8-4-PM-AMD-Studies.pdf
  • 43 - Supplying Chemicals Materials Equipments
  • 44 - 8-5-PM-AMD-Studies.pdf
  • 44 - Performing Method Development Studies
  • 45 - 8-6-PM-AMD-Studies.pdf
  • 45 - Determining Acceptance Criteria
  • 46 - 8-7-PM-AMD-Studies.pdf
  • 46 - Determining Dissolution Parameters
  • 47 - 8-8-PM-AMD-Studies.pdf
  • 47 - Performing Stress Studies
  • 48 - 8-9-PM-AMD-Studies.pdf
  • 48 - Performing PreValidation Studies

    • 9 - Formulation Studies for Generic Drug Development
  • 49 - 9-1-PM-FormulationforGDD.pdf
  • 49 - Formulation Studies for Generic Drug Development
  • 50 - 9-2-PM-FormulationforGDD.pdf
  • 50 - Performing Formulation Trials
  • 51 - 9-3-PM-FormulationforGDD.pdf
  • 51 - Optimizing Formulation by using QBD
  • 52 - 9-4-PM-FormulationforGDD.pdf
  • 52 - Supplying Chemicals RawMaterials Equipments for Pilot Manufacturing
  • 53 - 9-5-PM-FormulationforGDD.pdf
  • 53 - Preparing Formulations for Critical Material Attributes CMA
  • 54 - 9-6-PM-FormulationforGDD.pdf
  • 54 - Preparing Formulations for Critical Quality Attribute CQA
  • 55 - 9-7-PM-FormulationforGDD.pdf
  • 55 - Preparing Formulations for Critical Process Parameter CPP
  • 56 - 9-8-PM-FormulationforGDD.pdf
  • 56 - Discriminitive Dissolution Parameters
  • 57 - 9-9-PM-FormulationforGDD.pdf
  • 57 - Compatibility Study with Final Formula Components

    • 10 - Analytical Studies for Generic Drug Development
  • 58 - 10-1-PM-AnalyticalStudies.pdf
  • 58 - Analytical Studies for Generic Drug Development

    • 11 - Pilot Manufacturing for Generic Drug Development
  • 59 - Pilot Manufacturing for Generic Drug Development

    • 12 - Analysis of Pilot Batches for Generic Drug Development
  • 60 - 12-1-PM-AnalysisofPilotBatches.pdf
  • 60 - Analysis of Pilot Batches for Generic Drug Development

    • 13 - Performing Bioequivalency Study for Generic Drug Development
  • 61 - 13-1-PM-BioequivalencyStudy.pdf
  • 61 - Performing Bioequivalency Study for Generic Drug Development

    • 14 - Preparation Registration Dossier for Generic Drug Development
  • 62 - 14-1-PM-RegistrationDossier.pdf
  • 62 - Preparation Registration Dossier for Generic Drug Development

    • 15 - Conclusion
  • 63 - CONCLUSION-AYDANOZDEN.pdf
  • 63 - Conclusion
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    شناسه: 27807
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    مدت زمان: 338 دقیقه
    تاریخ انتشار: 28 آذر 1402
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