دورية أكاديمية
Clinical Drug Trials: The Path to the Patient.
| العنوان: | Clinical Drug Trials: The Path to the Patient. |
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| المؤلفون: | Diez Pascual C; León Research, S.L., Parque Tecnológico de León, C/ Nicostrato Vela s/n, León, Spain. cdiez@leonresearch.es. |
| المصدر: | Methods in molecular biology (Clifton, N.J.) [Methods Mol Biol] 2021; Vol. 2296, pp. 411-421. |
| نوع المنشور: | Journal Article; Review |
| اللغة: | English |
| بيانات الدورية: | Publisher: Humana Press Country of Publication: United States NLM ID: 9214969 Publication Model: Print Cited Medium: Internet ISSN: 1940-6029 (Electronic) Linking ISSN: 10643745 NLM ISO Abbreviation: Methods Mol Biol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Totowa, NJ : Humana Press Original Publication: Clifton, N.J. : Humana Press, |
| مواضيع طبية MeSH: | Clinical Trials as Topic*, Drug Discovery/*methods , Pharmaceutical Preparations/*administration & dosage, Animals ; Drug Approval/methods ; Drug-Related Side Effects and Adverse Reactions/prevention & control ; Humans ; Marketing/methods ; Randomized Controlled Trials as Topic |
| مستخلص: | The aim of this chapter is to describe and give an overview of the steps from the conception of an idea in the lab to reaching the market. Starting from the early discovery in the lab environment (including reverse and classical pharmacology), and briefly going over the different phases of clinical trials: Phase I, first tests in humans; Phase II, safety and efficacy; Phase III, efficacy confirmation; and Phase IV, post-authorization, in which the investigation would focus on long-term effects, completion of technical and safety sheet. Finally, a short conclusion in regard to the continuous overview and revision of drugs in the market. |
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| فهرسة مساهمة: | Keywords: Clinical research organization; Clinical trials; Drugs; Marketing authorization; Regulatory bodies; Research |
| المشرفين على المادة: | 0 (Pharmaceutical Preparations) |
| تواريخ الأحداث: | Date Created: 20210512 Date Completed: 20210622 Latest Revision: 20210622 |
| رمز التحديث: | 20240829 |
| DOI: | 10.1007/978-1-0716-1358-0_24 |
| PMID: | 33977462 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1940-6029 |
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| DOI: | 10.1007/978-1-0716-1358-0_24 |