Pre-IND meeting, etc

Take IND application as an example

• 

  CMC

  ◆ API:

  Process Research and Development, Manufacturing Process,

  Physical and Chemical Properties, Quality Research

  ◆ Formulation:

  Formulation Development,

  Manufacturing Process,

  Excipient Compatibility Study, Quality Research

  ◆ Quality Research – Impurities:

  Structure Identification and Analysis Methods of Impurity, Evaluation and 

  Analysis Methods of Genotoxic Impurities, Control of Elemental Impurities

  ◆ Compatibility of Packaging Materials:

  Study of Extractables/Leachables of Packaging Materials and Pipes

   

• 

  Non-clinical

  Safety — PD — PK

  ◆ Pharmacodynamic Animal Model

  ◆ Non-clinical Animal Species/Model

  ◆ Bioanalytical Method

  ◆ Toxicology NOAEL

• 

  Clinical

  ◆ Adverse Event Reporting:

  Definition of Adverse Event, Classification, etc

  ◆ Objective and Endpoint of Clinical trials:

  Primary Objective and Secondary Objective

  ◆ Clinical Trial Background and Introduction:

  Information Research, Principles of Clinical Development, Expected Risks, etc

  ◆ Criteria for inclusion and exclusion of subjects

  ◆ Indicators of Clinical Laboratory Examination

  ◆ Plan for Data Management and Statistical Analysis

Paper or electronic submission to the regulatory authority system: IND, NDA, ANDA, consistency evaluation, etc