Table 2 Backlog of questions addressed during the development of the new radio-conjuguate between TRL 2 and 4.

From: A hybrid innovation method based on quality by design and agile scrum paradigms for the development of medicinal products

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Question

Q.S1

As a developer, what are the critical input variables influencing the radiochemical conversion rate (RCC) during the manual synthesis ?

Q.S2

As a developer, what would be the range of values for the critical input variables that are compatible with the RCC specifications ?

Q.S3

As a developer, can the design space identified in the previous sprint be qualified to validate the initial proof of concept ?

Q.S4

As a developer, what happens to the design space when the synthesis is automated ?

Q.S5

As a developer, can the new operating region be qualified/validated with automated production ?