Features pharmaceutical development lyophilisate GK-2 for parenteral use

Author:

Blynskaya E. V.1,Tishkov S. V.1ORCID,Alekseyev K. V.1,Minaev S. V.1

Affiliation:

1. FSBI «Zakusov Institute of Pharmacology»

Publisher

Publishing House ABV Press

Reference7 articles.

1. ICH Q8. International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. Geneva, 2005. 28 r.

2. International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q9: Quality Risk Management, ICH. Geneva, Switzerland, 2005. 30 r.

3. Blynskaya E.V., Tishkov S.V., Alekseev K.V., Marakhova A.I. Vspomogatel'nye veshchestva v tekhnologii liofilizatsii peptidov i belkov. Farmatsiya 2017;66(1):14–8. [Blynskaya E.V., Tishkov S.V., Alekseev K.V., Marakhova A.I. Auxiliary substances in the technology of lyophilization of peptides and proteins. Farmatsya = Pharmacy 2017;66(1):14–8. (In Russ.)].

4. Blynskaya E.V., Tishkov S.V., Alekseev K.V. Tekhnologicheskie podkhody k sovershenstvovaniyu protsessa liofilizatsii belkovykh i peptidnykh lekarstvennykh preparatov. Rossiiskii bioterapevticheskii zhurnal 2017;16(1):6–11. DOI: 10.17650/1726-9784-2017-16-1-6-11. [Blynskaya E.V., Tishkov S.V., Alekseev K.V. Technological approaches to improving the process of lyophilization of protein and peptide drugs. Rossiysky Bioterapevtichesky Zhurnal = Russian Journal of Biotherapy 2017;16(1):6–11. (In Russ.)].

5. Gulyakin I.D., Khashem Ali, Nikolaeva L.L. i dr. Razrabotka novoi tekhnologii polucheniya lekarstvennoi formy dlya vnutrivennogo vvedeniya proizvodnogo indolokarbazola LKhS-1208. Rossiiskii bioterapevticheskii zhurnal 2016;15(2):55–60. DOI: 10.17650/1726-9784-2016-15-2-55-60. [Gulyakin I.D., Hashem Ali, Nikolaeva L.L. et al. Development of a new technology for the preparation of a dosage form for the intravenous administration of an indole carbazole derivative, LHS-1208. Rossiysky Bioterapevtichesky Zhurnal = Russian Journal of Biotherapy 2016;15(2):55–60. (In Russ.)].

Cited by 2 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

1. Features of risk analysis, assessment and control methods in pharmaceutical development;Russian Journal of Biotherapy;2023-04-17

2. Using mathematical modeling to optimize secondary drying stage of lyophilization technology;Farmacevticheskoe delo i tehnologija lekarstv (Pharmacy and Pharmaceutical Technology);2020-02-01

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