JYMed e ka fana ka li-peptide'API le peptide li qetile nts'etsopele ea litekanyetso tsa projeke ea hau, joalo ka ka tlase:

[Tlhaloso ea Batho]

CQA

QBD

Ntlafatso le boikemisetso ba ts'ebetso

Ntlafatso ea ts'ebetso

3 tlhahiso ea li-batches ho lekola monyetla oa ho hola

1-3 batches tlhahiso ea tekanyo ea teko

Sebopeho

Lihlahisoa tse 3 tsa netefatso

ICH Boithuto ba botsitso

Tlhahiso ea Mehlala ea Clinical

[Tlhaloso ea Litlhahlobo]

Nts'etsopele ea mekhoa ea tlhahlobo ea lintho tse amanang le tlhahlobo

Thuto ea litšila

Nts'etsopele ea mekhoa ea ho hlahloba: GC, IC, tlhahlobo ea amino acid, li-ion tsa counter le mekhoa ea bohloeki

Ho Thehwa ha Tlhaloso

Tokisetso ea Boemo ba Mosebetsi

Ho netefatsa mokhoa oa ho hlahloba

[Litokomane tsa Molao]

Kakaretso ea data le ho tlatsa DMF

Tšehetso ea Taolo ka pel'a US FDA/EDQM