ISPE

MARCH 29, 2023

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. Table 1: Linkage among patient consideration, product design, target attributes and CQAs.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. Table 1: Linkage among patient consideration, product design, target attributes and CQAs.

Documentation 52

Documentation Dosage Packaging Communication 52

Pharmaceutical Technology

JANUARY 6, 2023

At the centre of the case was Gilenya’s ‘405 patent, which details methods for treating relapsing multiple sclerosis with a specific dosage of the drug. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies.

Documentation 97

Documentation FDA Hospitals Dosage 97