Basic research

Seed ideas

Preclinical: Discovery

Clinical development

Approval

Optimization

Phase I

Phase II

Phase III

Safety & manufacturing

- lead generation

- assay development

- method development

- lead candidate

- process development

- assay validation

- development plan

- gap analysis

- animal models

- proof of concept

- drug delivery

- ADME

- formulation

- IND enabeling studies

- IND application

- preclinical plan

- CRO selection

- SOPs

- QMS

GLP & GCP requirements

GMP requirements

Identification

- targed identification

- first efficacy data

FIGURE 5.7 Typical stages of drug development from basic research to approval and market authorization. GLP: Good Laboratory Practice; GCP:

Good Clinical Practice; GMP: Good Manufacturing Practice; ADME: Adsorption, Distribution, Metabolism, and Excretion; CRO: Contract Research

Organization; IND: Investigational New Drug; SOP: Standard Operating Procedure; QMS: Quality Management System.

Upstream processing for viral vaccines

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