JYMed nwere ike inye peptides'API na peptide emechaala usoro onunu ogwu maka oru ngo gi, dika n'okpuru:

[mmepe mmadụ]

CQA

QBD

Mmepe na mkpebi siri ike nke usoro

Nkwalite usoro

Mmepụta batches 3 iji chọpụta na ọ ga-ekwe omume ịbawanye elu

1-3 batches pilot ọnụ ọgụgụ mmepụta

Njiri mara

3 nkwado batches mmepụta

Ọmụmụ ICH Stability

Mmepụta Sample Clinical

[Nkwalite nyocha]

Mmepe nke ụzọ nyocha nke ihe metụtara ya na nyocha

Ọmụmụ adịghị ọcha

Mmepe nke ụzọ nyocha: GC, IC, amino acid analysis, counter ion na ụzọ ịdị ọcha

Ntọala nkọwapụta

Nkwadebe ọkọlọtọ na-arụ ọrụ

Nkwado usoro nyocha

[Akwụkwọ iwu]

Nchịkọta data na njuputa DMF

Nkwado usoro iwu n'ihu US FDA/EDQM