| Kode Mata Kuliah | FK4143 / 2 SKS |
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| Penyelenggara | 116 - Clinical and Community Pharmacy / SF |
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| Kategori | Lecture |
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| Bahasa Indonesia | English |
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| Nama Mata Kuliah | Evaluasi Khasiat dan Keamanan Obat | Evaluation of Drug Efficacy and Safety |
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| Bahan Kajian | - Jenis-jenis desain uji pre-klinik
- Jenis-jenis desain uji klinik
- Desain dan evaluasi data uji klinik eksperimental
- Desain dan evaluasi data uji klinik observasional
- Critical appraisal
- Evidence Based Medicine
| - Types of Pre-Clinical Study Designs
- Types of Clinical Study Designs
- Design and Evaluation of Experimental Clinical Data
- Design and Evaluation of Observational Clinical Data
- Critical Appraisal
- Evidence-Based Medicine
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| Capaian Pembelajaran Mata Kuliah (CPMK) | - Mampu mendeskripsikan jenis-jenis desain uji pre-klinik
- Mampu mendeskripsikan jenis-jenis desain uji klinik (observasional, dan eksperimental)
- Mampu mengevaluasi data hasil uji pre-klinik dan klinik
- Mampu menyusun rekomendasi hasil evaluasi khasiat dan keamanan obat dari data uji pre-klinik dan/atau klinik
| - Able to describe the types of pre-clinical study designs
- Able to describe the types of clinical study designs (observational and experimental)
- Able to evaluate pre-clinical and clinical test data
- Able to prepare recommendations based on the evaluation of drug efficacy and safety from pre-clinical and/or clinical test data
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| Metode Pembelajaran | Kuliah, Project-based studi berkelompok, Presentasi | Lectures, group project-based study, presentations |
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| Modalitas Pembelajaran | Visual, Auditorial, Project-based study berkelompok. Pelaksanaan secara sinkronous | Visual, auditory, project-based group study. Conducted synchronously |
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| Jenis Nilai | ABCDE |
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| Metode Penilaian | UTS, UAS, Kuis, Tugas | Mid-semester exam, final exam, quiz, assignment |
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| Catatan Tambahan | | |
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