仿制药开发技术项目管理
上次更新时间：2024-10-26
课程售价: 2.9 元
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课程内容
1 - Introduction
2 - Introduction to Generic Drug Development
- 2 - Active Pharmaceutical Ingredient API Finished Pharmaceutical Product FPP (免费)
- 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
4 - Project Management for Generic Drug Development
5 - Desk Research for Generic Drug Development
6 - Raw Material Selection for Generic Drug Development
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
11 - Pilot Manufacturing for Generic Drug Development
12 - Analysis of Pilot Batches for Generic Drug Development
13 - Performing Bioequivalency Study for Generic Drug Development
14 - Preparation Registration Dossier for Generic Drug Development
15 - Conclusion
课程内容
15个章节 , 64个讲座
1 - Introduction
2 - Introduction to Generic Drug Development
- 2 - Active Pharmaceutical Ingredient API Finished Pharmaceutical Product FPP (免费)
- 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
4 - Project Management for Generic Drug Development
5 - Desk Research for Generic Drug Development
6 - Raw Material Selection for Generic Drug Development
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