JYMed ka fana ka peptides ' API le peptide qetile ntshetsopeleng litekanyetso li behoa bakeng sa porojeke e ne hao, e le ka tlase:
[Tlhaloso ea Batho]
CQA
QBD
Ntshetsopele le boikemisetso ba thulaganyou e
Gogolo tsa thulaganyou e
3 batches ho hlahisoeng hlahloba ho bokgono ho hloa ho fihlela
1-3 batches ho hlahisoeng motsamaisi tekanyo e
Sebopeho
tlhahiso ea 3 netefaletsokaelo batches
ho ithuta ICH botsitso
Clinical tlhahiso ea Sample
[Go katisediwa go Development]
Ntshetsopeleng ya mekhoa katisediwa tsa ntho tse amanang le thlahlobo
ho ithuta se hloeke
Ntshetsopeleng ya mekhoa katisediwa: reba, edy, ho hlahloba amino acid e, stats ions le mekhoa ea bohloeki
Ho thehoa ha ga tlhaloso
Sebetsa Standard itokisa
Netefaletsokaelo mokhoa katisediwa
[Molawana Litokomane]
Kakaretso ya data le DMF rarollela
Taolo Support ka pel'a US FDA / EDQM