JYMed anogona kupa peptides '  API uye peptide apedza chipimo chemushonga kukura nokuda ramunoda, sezvo pazasi:

[Kubudirira Kwevanhu]

CQA

QBD

Development uye Kutsunga kwacho

Optimization kuti urongwa

3 batch kugadzirwa rokuongorora feasibility kuti kukwira kumusoro

1-3 batch mutyairi wendege pakafunuka kugadzirwa

Characterization

3 chivimbo chakasimba batch kugadzirwa

I Kugadzikana kudzidza

Clinical kugadzirwa Mharidzo

[Analytical Development]

Kugadzirwa Analytical nzira kufanana nenhumbi uye munhu akaidza

kumwedzi kudzidza

Kugadzirwa Analytical nzira: GC, IC, amino iine acid pachisara pakaunda ions uye utsanana nzira

Pokugadzwa Specification

Kushanda Standard Kugadzirira

Chivimbo chakasimba pamusoro Analytical nzira

[Regulation Documents]

Pfupiso date uye DMF zvekupfakira

Support pamutemo pamberi US FDA / EDQM