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Table 1 Overview of case studies

From: Utilization of risk-based predictive stability within regulatory submissions; industry’s experience

Case study no.

Description

Phase

Material

Submission Content in Addition to Predictive Dataa

Territories

Accepted

Questioned

1

Setting initial retest period and shelf-life

Phase 1

Drug substance and oral solution

Limited long-term data for drug substance

Belgium

 

2

Setting shelf-life of formulation variant

Phase 1

Tablet

Limited long-term data

USA, UK, France, Italy, Turkey, Egypt, Lebanon, Kenya

 

3

Setting shelf-life of formulation variant

Phase 1

Capsule

Limited long-term data

USA

 

4

Setting initial retest period and shelf-life

Phase 1

Drug substance and IV solution

None

Netherlands, Germany (drug substance)

UK, Germany (drug product)

5

Setting initial retest period and shelf-life

Phase 1

Drug substance and tablet

None

USA

UK

6

Setting initial shelf-life

Phase 1

Tablet

None

Belgium, Moldova, Bulgaria, Georgia

France, Spain

7

Setting initial shelf-life

Phase 1

Powder for oral solution and tablet

None

 

Germany

8

Setting shelf-life of formulation variant

Phase 1

Capsule

None

USA, Spain, France

 

9

Setting initial shelf-life

Phase 2

Tablets

None

USA, Belgium

 

10

Setting initial shelf-life

Phase 2

Modified release formulation

None

USA, Belgium

 

11

Setting shelf-life of formulation variant

Phase 2

Tablet

None

USA, Spain, France

Germany

12

Justify storage condition for drug substance with a new process, and predict shelf-life for a new formulation

Phase 2

Drug Substance and Tablet

Limited long-term data for drug substance, Limited long-term data for drug product

USA

 

13

Setting shelf-life of formulation variant

Phase 2

Tablet

Limited long-term data

UK (but with reduced shelf-life)

 

14

Impact of drug product process change on shelf-life

Phase 3

Tablet

Limited long-term data

USA, Canada, Russia, Taiwan, Poland, Ukraine, Japan

 

15

Setting shelf-life of formulation variant

Phase 3

Capsule

Supportive information from previous formulations

Belgium, Brazil, Canada, China, India, Denmark. Finland, France, Ireland, Italy, Netherlands, Portugal, Spain, Taiwan, Turkey

UK, Korea, Germany

16

Justification of strategy for water testing on stability

Registration

Tablet

Predictive dissolution model

USA, EU

 

17

Justification of degradant end of life specification

Registration

Tablet

Limited long-term data

USA, EU, Canada, Australia, Asia Pacific and Latin America

 
  1. aDoes not reflect additional data provided in response to regulatory queries