Rarraba Harka Daya
Case-Melatonin
1. Sabon magani, nemi mai sana'anta API.
2. Manufacturers ake bukata don samar da cancantar da takardun.
3, EP/BP/USP misali suna aiki.
4. Yi tsammanin rajista tare da DMF a cikin watanni 6.
5. Bayyana bisa ga bukatun kasuwar abu.
Martani daga Hande
1. Sadarwa tare da abokan ciniki akan lokaci don fahimtar bukatun abokin ciniki.
2. Ƙarin bincike akan samfurin: 480 + gwaje-gwaje na asibiti; Akwai 2 DMF sanarwa a Amurka, babu CN. A kasashe masu tasowa, babu DMF na CN.
3, Fahimtar da DMF jerawa bukatun na kasashe masu tasowa; R&D, QA rayayye tattauna; Ku zo tare da abokin ciniki a cikin mako guda da kuma cimma yarjejeniya; Hande ta bayar da rahoto tawagar, da shekaru na duniya rahoton gwaninta, da DMF jerawa za a kammala a cikin 3M; 3M a baya fiye da yadda ake tsammani.
4. Aiwatar da DMF kamar yadda aka tsarkake 98%+, ana ci gaba.
Rarraba Harka Biyu
Case-Ecdysterone 1
1. Gwajin gwaji na asibiti na ɗan adam, EU da US mktg.
2, A baya maroki ne ba yarda, da sabon maroki bukatar saduwa da EU GMP bukatun, da cikakken gwaji damar, iya yarda da ingancin audits da kuma hada kai tare da tsari rajista, kuma suna da barga wadata damar.
Martani daga Hande
1. Sadarwa tare da abokan ciniki akan lokaci don fahimtar bukatun abokin ciniki.
2, More bincike a kan samfurin: A halin yanzu, yafi amfani a cikin dabbobi kwayoyi, abinci kari, da high-karshen kayan shafawa; Wannan shi ne na farko idan akwai ecdysone shafi mutum magani, A halin yanzu a Phase III CT.
3. Babu wani daga cikin masu samar da ecdysone a halin yanzu akan kasuwa da zai iya gamsar da ingantaccen bincike da buƙatun biyan bukatun abokan ciniki.
4. An tattauna a ciki; Karɓi 3 audits, m 1 da onsite 2.
5. Yanzu Hande ita ce ƙwararren mai samar da ita.
Raba Harka Uku
Case-Ecdysterone 2
1. Masu Kariyar Abincin Abinci na Ƙasashen Waje.
2, Saboda tambaya na dabara da masu amfani da, shirye don inganta sabon girke-girke.
3. The bukatun ga sabon dabara ba musamman bayyananne, bukatar goyon bayan manufacturer ta bayanai da gwaji.
Martani daga Hande
1, Sadarwa tare da abokan ciniki dace don fahimtar abokin ciniki bukatun: 20E bukatar da za a fili gano; Da dama sauran shuka tsantsa sinadaran ake bukata; A nan gaba dabara ne da za'ayi bisa ga rabo daga cikin wadannan plantings.
2, R&D, QA tattaunawa rayayye; Ku zo tare da abokin ciniki tare da cikakkun buƙatun.
3. Rayayye ba da shawarar yin girke-girke tare da mahara monomers, daya-tasha-shop mafita.
4, Hande ya zama mai karfi samar goyon baya ga wannan abokin ciniki.
Rarraba Harka Hudu
Case-Cepharanthine
1. A matsayin sabon magani mai yuwuwa don maganin COVID-19, ya zama dole a nemo masu samar da kayayyaki waɗanda ke da fasaha, yanayin samarwa, kuma suna iya yin bincike da bayyana API.
2. Bukatar yin aiki tare da gwajin gwaji.
3. Bukatar samar da dacewa adabi kamar tasiri dalilai.
Martani daga Hande
1. Sadarwa tare da abokan ciniki akan lokaci don fahimtar bukatun abokin ciniki.
2, R&D, QA tattaunawa rayayye; Ku zo tare da abokin ciniki tare da cikakkun buƙatun.
3. Hande ya riga ya sami takardar shaidar Cepharanthine na rabuwa da kuma hanyar cirewa a farkon 2011 A cikin lokacin da abokin ciniki ya yi tsammani, kammala ƙananan gwajin zuwa tsakiyar gwajin, da kuma samar da tallafin wallafe-wallafe a cikin tsari.
4. Yanzu Hande ya zama abokin tarayya, kuma yana yin shawarwari tare da haɗin gwiwa mai zurfi.