●全講義資料● >>一括ダウンロード(prd2018.zip 127MB)
- モジュール 1 "Introduction" (8月 20日) -
| Overview of product research and development and stakeholders | Professor Dr. Juntra Karbwang | |
- モジュール 2 "Drug Discovery and Development" (8月 20日〜 8月 23日) -
| History and overview of drug discovery, The role of Genomics and bioinformatics, High throughput screening: Pre-requisite of HITS systems, Assay Development & Validation, Biochemical & Cell-based assay, Assay Readout & Detection, The role of Chemistry in Drug Discovery: -Lead Identification, -Lead Generation Libraries (Combinatiorial Chemistry, Computational Approches), -Lead Optimization |
Professor Dr.Yoshimasa Tanaka | |
| Drug Discovery in Academia Pharmacokinetic Issues in Drug Discovery: - Designs and Purposes of DMPK Profiles of Lead & Drug Candidates - DMPK studies in Drug Discovery (Late lead identification & Early lead optimization, Mid lead optimization, Late lead optimization) - Examples |
Professor Dr. Kesara Na-Bangchang | |
| The role of Pharmacology - PharmacologicalEvaluations (Selectivityscreening, Pharmacologicalprofiling, Testing in animalmodels of disease, Safety pharmacology) - Examples |
Professor Dr.Yoshimasa Tanaka | |
| Overview: Pre-clinical studyrequiments for human clinical studies | Professor Dr. Kesara Na-Bangchang | |
| Assessing of Drug Safety:the role of toxicology - Objective and Type ofToxicology - Exploratory Toxicology - Regulatory Toxicology - Toxicity Measures andToxicity Test |
Assistant Prof. Supatra Porasuphatana | |
| Pharmaceutical Development and CMC | Professor Dr. Hitoshi Sasaki | |
| Patents in Drug Discovery: - Publication VS Patents - Patent system - Type of Patent |
Professor Dr. Hiroshi Kato | |
| Overview of clinical development | Professor Dr. Juntra Karbwang | |
| Regulatory Framework | Dr. Hiroshi Yamamoto | |
| Investigational Phases of Clinical Research (I-IV) and Study Design | Professor Dr. Juntra Karbwang | |
| Clinical Development Plan | Professor Dr. Juntra Karbwang | |
| Pharmacogenomics - Anticipated Benefits - Polymorphisms in Drug Targets - Polymorphisms in ADME - Pharmacogenomics Testing - Pharmacogenomics in Clinical Trials - Examples |
Dr.Shyh-Yuh Liou | |
| Pharmacokinetics (Non-clinical & Clinical) | Professor Dr. Kesara Na-Bangchang | |
| Biopharmaceuticals - Development of Biopharmaceuticals - Type of Biopharmaceuticals - Issues related to the use of Biopharmaceuticals (Antigenicity, Stability, Drug delivery) |
Assistant Prof. Supatra Porasuphatana | |
| Introduction of Traditional Medicine and guidance on herbal medicines | Professor Dr. Kiichiro Tsutani | |
| Regulation for traditional medicine development | ProfessorDr.Ichiro Arai | |
- モジュール 3 "Vaccine Discovery and Development" (8月 24日〜 8月 28日) -
| Historical overview of vaccine Discovery Vaccines for infection control |
Assistant Professor Dr. Shusaku Mizukami | |
| Vaccine Platform Technology and Adjuvant Development CMC Immunogenicity and protect activity Safety assessment:Toxicity test in animals: regional complications, systemic toxicity |
Dr. Takeshi Arakawa | |
| Assessment of pre-clinical information Clinical development plan Dose selection and regimen |
Dr.Daisuke Tsuzuki | |
- モジュール 4 "Diagnostic Development" (8月 29日) -
| Development of molecular diagnostic tests for emerging infectious | Assistant Professor Dr,Yohei Kurosaki | |
| Development of diagnostic tests for arbovirus | Associate Professor Dr,Shingo Inoue | |
- モジュール 5 "Good Clinical Practice" (8月 23日) -
| Principles of Research Ethics and Ethics codes and Guidance | Professor Dr. Juntra Karbwang | |
| Responsibilities: Sponsor, Monitors, audit, DSMB | Professor Dr. Juntra Karbwang | |
| Clinical Data Management | Professor Dr. Kesara Na-Bangchang | |
- モジュール 6 "Post-registration Activities" (8月 30日) -
Describe post-registration activities for medicinal products
August 30, Thursday (Day 9)
| Overview | Professor Dr, Chitr Sitthi-amorn | |
| How to solve Access to Medicines (ATM) problems in developing countries | Professor Dr, Chitr Sitthi-amorn | |
| Improving the quality of new products in health systems: International network of rational use of drugs | Professor Dr, Chitr Sitthi-amorn | |
| Post-marketing product vigilance | Professor Dr, Chitr Sitthi-amorn | |
| Stakeholders to be involved in making product development work for the intended | Professor Dr, Chitr Sitthi-amorn | |