I-JYMed inganikeza ama-peptides'I-API ne-peptide kuqedile ukuthuthukiswa komthamo wephrojekthi yakho, njengoba ngezansi:

[Ukuthuthukiswa Kwabantu]

I-CQA

QBD

Ukuthuthukiswa nokunqunywa kwenqubo

Ukuthuthukisa inqubo

3 amaqoqo okukhiqiza ukuhlola ukuthi kungenzeka yini ukukhuphula

1-3 amaqoqo okukhiqizwa kwesikali sokuhlola

Ukwenziwa kwezinhlamvu

3 ukukhiqizwa kwamaqoqo okuqinisekisa

Ucwaningo lokuzinza lwe-ICH

Ukukhiqizwa Kwesampula Lomtholampilo

[Ukuthuthukiswa Kokuhlaziya]

Ukuthuthukiswa kwezindlela zokuhlaziya zezinto ezihlobene nokuhlola

Ucwaningo lokungcola

Ukuthuthukiswa kwezindlela zokuhlaziya: i-GC, i-IC, ukuhlaziywa kwe-amino acid, i-counter ion nezindlela zokuhlanzeka

Ukusungulwa Kwezicaciso

Ukulungiselela Okujwayelekile Okusebenzayo

Ukuqinisekiswa kwendlela yokuhlaziya

[Amadokhumenti Omthetho]

Isifinyezo sedatha nokugcwaliswa kwe-DMF

Ukwesekwa Kokulawula phambi kwe-US FDA/EDQM