仿制药开发技术项目管理
- 1 - Introduction
- 1 - Introduction
- 2 - Introduction to Generic Drug Development
- 2 - Active Pharmaceutical Ingredient API Finished Pharmaceutical Product FPP
- 3 - Reference Listed Drug RLD Generic Multisource Pharmaceutical Products
- 4 - Pharmaceutical Bioequivalency Therapeutic Equivalency
- 5 - Reference Listed Drug RLD Development
- 6 - Generic Drug Development
- 7 - Comparision of Reference Listed Drug RLD Development Generic Drug Developmen
- 8 - Invitro Invivo Studies for Drug Product
- 3 - Introduction to Project Management
- 9 - Project Elements of Project Cost Time Scope
- 10 - Priorizitation of Project Pipeline
- 11 - Project Phases
- 12 - Project Manager
- 13 - Project Team Project Stakeholders
- 14 - Project Management Tools
- 4 - Project Management for Generic Drug Development
- 15 - Project Diary for Generic Drug Development
- 16 - Project Milestones for Generic Drug Development
- 17 - Project Gantt Chart for Generic Drug Development
- 18 - Generic Drug Development Project Phases
- 5 - Desk Research for Generic Drug Development
- 19 - Desk Research for Generic Drug Development
- 20 - European Medicines Agency EMA
- 21 - World Health Organization WHO Food and Drug Administration FDA
- 22 - Pharmacopoeias Dailymed
- 23 - Drugscom
- 24 - DrugBank
- 25 - Google Patents
- 26 - Espacenet
- 6 - Raw Material Selection for Generic Drug Development
- 27 - Raw Material Selection for Generic Drug Development
- 28 - Evaluation of Characteristics of API
- 29 - Stability Characteristics of API
- 30 - Evaluation of Suppliers of API
- 31 - Evaluation of Inactive Ingredient and Packaging Material
- 7 - PreFormulation Studies for Generic Drug Development
- 32 - PreFormulation Studies for Generic Drug Development
- 33 - Characterization of RLD
- 34 - Defining Quality Target Product Profile QTPP
- 35 - 74
- 35 - Evaluation of BE Requirements
- 36 - Evaluation of Inactive Ingredient Required for Formula
- 37 - Compatibility Study
- 38 - Supplying New material Apparatus Equipment
- 39 - Performing PreFormulation Trials
- 8 - Analytical Method Development Studies for Generic Drug Development
- 40 - Analytical Method Development Studies for Generic Drug Development 1
- 41 - Analytical Method Development Studies for Generic Drug Development 2
- 42 - Literature Search for Analytical Method Development
- 43 - Supplying Chemicals Materials Equipments
- 44 - Performing Method Development Studies
- 45 - Determining Acceptance Criteria
- 46 - Determining Dissolution Parameters
- 47 - Performing Stress Studies
- 48 - Performing PreValidation Studies
- 9 - Formulation Studies for Generic Drug Development
- 49 - Formulation Studies for Generic Drug Development
- 50 - Performing Formulation Trials
- 51 - Optimizing Formulation by using QBD
- 52 - Supplying Chemicals RawMaterials Equipments for Pilot Manufacturing
- 53 - Preparing Formulations for Critical Material Attributes CMA
- 54 - Preparing Formulations for Critical Quality Attribute CQA
- 55 - Preparing Formulations for Critical Process Parameter CPP
- 56 - Discriminitive Dissolution Parameters
- 57 - Compatibility Study with Final Formula Components
- 10 - Analytical Studies for Generic Drug Development
- 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 - Analysis of Pilot Batches for Generic Drug Development
- 13 - Performing Bioequivalency Study for Generic Drug Development
- 61 - Performing Bioequivalency Study for Generic Drug Development
- 14 - Preparation Registration Dossier for Generic Drug Development
- 62 - Preparation Registration Dossier for Generic Drug Development
- 15 - Conclusion
- 63 - Conclusion