Think Rare, Think Inside and Out: Simple Question-Based Approach to Complex Rare Disease Drug Development

Indranil Bhattacharya; Mariam A Ahmed

doi:10.1002/jcph.2173

Think Rare, Think Inside and Out: Simple Question-Based Approach to Complex Rare Disease Drug Development

J Clin Pharmacol. 2022 Dec:62 Suppl 2:S6-S11. doi: 10.1002/jcph.2173.

Authors

Indranil Bhattacharya¹, Mariam A Ahmed¹

Affiliation

¹ Quantitative Clinical Pharmacology, Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.

PMID: 36461741
DOI: 10.1002/jcph.2173

No abstract available

Keywords: clinical pharmacology (CPH); drug development; model-informed drug development; modeling and simulation; rare diseases; regulatory/scientific affairs (REG).

MeSH terms

Drug Development*
Humans
Rare Diseases* / drug therapy