I-JYMed inokubonelela ngeepeptides'I-API kunye ne-peptide igqibile uphuhliso lwedosi yeprojekthi yakho, njengezantsi:

[uPhuhliso loLuntu]

CQA

QBD

Uphuhliso kunye nokumiselwa kwenkqubo

Ukuphucula inkqubo

Imveliso yeebhetshi ezi-3 ukuvavanya ukubanakho ukunyusa

Iibhetshi ezi-1 ukuya kwezi-3 zemveliso yesikali sokulinga

Ubume beempawu

Imveliso yeebhetshi ezi-3 zokuqinisekisa

Isifundo sozinzo lwe-ICH

Ukuveliswa kweSampule yeKliniki

[Uphuhliso lohlalutyo]

Ukuphuhliswa kweendlela zohlalutyo lwento enxulumeneyo kunye novavanyo

Ukufundwa kokungcola

Ukuphuhliswa kweendlela zokuhlalutya: i-GC, i-IC, uhlalutyo lwe-amino acid, i-counter ion kunye neendlela zokucoceka

Ukusekwa kweNkcazo

Ukulungiselela uMgangatho wokuSebenza

Ukuqinisekiswa kwendlela yohlalutyo

[Amaxwebhu oMgaqo]

Isishwankathelo sedatha kunye nokuzaliswa kweDMF

Inkxaso yoLawulo phambi kwe-US FDA/EDQM