Validation of critical process input parameters in the production of protein pharmaceutical products: a strategy for validating new processes or revalidating existing processes.

Martin-Moe S; Ellis J; Coan M; Victor R; Savage J; Bogren N; Leng B; Lee C; Burnett M; Montgomery P

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Validation of critical process input parameters in the production of protein pharmaceutical products: a strategy for validating new processes or revalidating existing processes.

机译：验证蛋白药物产品生产中的关键过程输入参数：验证新过程或重新验证现有过程的策略。

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来源
《PDA journal of pharmaceutical science and technology》 |2000年第4期|共5页
作者
Martin-Moe S; Ellis J; Coan M; Victor R; Savage J; Bogren N; Leng B; Lee C; Burnett M; Montgomery P;
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正文语种 eng
中图分类药学;
关键词
Proteins; Technology; Pharmaceutical; 蛋白质类; 工艺学; 制药;

机译：Proteins;Technology;Pharmaceutical;蛋白质类;工艺学;制药;

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1. Validation of critical process input parameters in the production of protein pharmaceutical products: a strategy for validating new processes or revalidating existing processes. [J] . Martin-Moe S, Ellis J, Coan M, PDA journal of pharmaceutical science and technology . 2000,第4期

机译：验证蛋白药物产品生产中的关键过程输入参数：验证新过程或重新验证现有过程的策略。
2. Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes. [J] . De Beer T, Burggraeve A, Fonteyne M, International Journal of Pharmaceutics . 2011,第1a2期

机译：近红外和拉曼光谱用于药物生产过程的过程监控。
3. Development, validation and transfer of a near infrared method to determine in-line the end point of a fluidised drying process for commercial production batches of an approved oral solid dose pharmaceutical product. [J] . Peinado A, Hammond J, Scott A Journal of Pharmaceutical and Biomedical Analysis: An International Journal on All Drug-Related Topics in Pharmaceutical, Biomedical and Clinical Analysis . 2011,第1期

机译：开发，验证和转移一种近红外方法，以在线确定批准的口服固体剂型药物产品的商业生产批次的流化干燥过程的终点。
4. Data Validation and Modelling of Thermodynamic Properties of Systems with Active Pharmaceutical Ingredients (APIs) in Complex Media for Skin Absorption Processes [C] . Lukasz Ruszczynski, Alexandr Zubov, Gilrkan Sin European Symposium on Computer Aided Process Engineering . 2017

机译：具有活性药物成分（API）在复杂介质中的系统热力学性质的数据验证及建模，用于皮肤吸收过程
5. Application of process analytical technology to plasma-derived protein pharmaceutical manufacturing processes. [D] . Nalbandyan, Lilit. 2014

机译：过程分析技术在血浆蛋白生产过程中的应用。
6. Identification and Characterization of an Oxidative Degradation Product of Fexofenadine Development and Validation of a Stability-Indicating RP-UPLC Method for the Estimation of Process Related Impurities and Degradation Products of Fexofenadine in Pharmaceutical Formulations [O] . Bhupendrasinh Vaghela, Surendra Singh Rao, Annarapu Malleshwar Reddy, 2012

机译：非索非那定氧化降解产物的鉴定表征稳定性指示RP-UPLC方法的开发和验证该方法用于估算与制剂有关的非索非那定的工艺相关杂质和降解产物
7. Degradation and Microbiological Validation of Meropenem Antibiotic in Aqueous Solution Using UV, UV/H2O2, UV/TiO2 and UV/TiO2/H2O2 Processes. [O] . Priyanshu Verma, Jatinder Kumar 2014

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8. New Metamodeling Approach for Time-dependent Reliability of Dynamic Systems with Random Parameters Excited by Input Random Processes. [R] . Baseski, I., Drignei, D., Mourelatos, Z. P., 2014

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Validation of critical process input parameters in the production of protein pharmaceutical products: a strategy for validating new processes or revalidating existing processes.

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