IND-enabling studies 

The primary regulatory framework includes: 

• ICH M3(R2), which describes the non-clinical safety studies needed to support clinical trials and marketing authorisation 
• ICH S3A and S3B, which address toxicokinetics and repeated-dose tissue distribution
• FDA guidance on Metabolites in Safety Testing (MIST) 
• relevant EMA and national guidance for IND- or IMPD-supporting packages. 

The exact package depends on compound class, route of administration, intended patient population, duration of treatment and stage of development. 

A typical IND/IMPD-enabling DMPK package may include: 

• plasma protein binding 
• blood-to-plasma ratio 
• in vitro metabolic stability and metabolite identification 
• CYP and transporter interaction studies 
• PK and toxicokinetic studies in rodents and non-rodents 
• metabolite profiling in toxicology species 
• radiolabelled ADME or mass balance studies where needed 
• human PK prediction and dose projection. 

The final package should be tailored to the compound and development strategy. 

Every IND/IMPD-enabling DMPK program should be tailored to the individual drug candidate. Study selection depends on the compound’s properties, target indication, patient population, intended route of administration, treatment duration and regulatory context.

Nuvisan’s approach is to design development packages that are scientifically justified, operationally efficient and aligned with regulatory expectations for the specific asset.