JYMed inogona kupa peptides'API uye peptide yapedza dosage kuvandudzwa kweprojekiti yako, sepazasi:

[Kubudirira Kwevanhu]

CQA

QBD

Kubudirira uye kutsunga kwemaitiro

Optimization of process

3 batches kugadzirwa kuongorora kugona kukwira kumusoro

1-3 batches pilot scale kugadzirwa

Characterization

3 yekusimbisa batches kugadzirwa

ICH Kugadzikana kudzidza

Clinical Sample kugadzirwa

[Analytical Development]

Kuvandudza nzira dzekuongorora dzezvinhu zvine hukama uye assay

Kudzidza kusachena

Kuvandudza nzira dzekuongorora: GC, IC, amino acid kuongororwa, counter ions uye nzira dzehutsanana

Kugadzwa kweSpecification

Kushanda Standard Kugadzirira

Kusimbisa nzira yekuongorora

[Regulation Documents]

Pfupiso yedata uye DMF kuzadza

Regulatory Tsigiro pamberi peUS FDA/EDQM