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Re-engineering clinical trials : best practices for streamlining the development process /
The pharmaceutical industry is currently operating under a business model that is not sustainable for the future. Given the high costs associated with drug development, there is a vital need to reform this process in order to provide safe and effective drugs while still securing a profit. Re-Enginee...
| Clasificación: | Libro Electrónico |
|---|---|
| Otros Autores: | , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Amsterdam :
Academic Press,
2015.
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| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 020 | |a 0128007907 |q (electronic bk.) | ||
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| 020 | |z 0124202462 |q (hbk.) | ||
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| 245 | 0 | 0 | |a Re-engineering clinical trials : |b best practices for streamlining the development process / |c edited by Peter Sch�uler, Brendan Buckley. |
| 264 | 1 | |a Amsterdam : |b Academic Press, |c 2015. | |
| 300 | |a 1 online resource (383 pages) : |b illustrations (some color) | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 588 | 0 | |a Print version record. | |
| 520 | |a The pharmaceutical industry is currently operating under a business model that is not sustainable for the future. Given the high costs associated with drug development, there is a vital need to reform this process in order to provide safe and effective drugs while still securing a profit. Re-Engineering Clinical Trials evaluates the trends and challenges associated with the current drug development process and presents solutions that integrate the use of modern communication technologies, innovations and novel enrichment designs. This book focuses on the need to simplify drug development and ... | ||
| 505 | 0 | |a Front Cover; RE-ENGINEERING CLINICAL TRIALS: Best Practices for Streamlining Drug Development; Copyright; CONTENTS; LIST OF CONTRIBUTORS; INTRODUCTION; REFERENCES; SECTION 1 -- Why Does the Industry Need a Change?; Chapter 1 -- Why Is the Pharmaceutical and Biotechnology Industry Struggling?; 1. INTRODUCTION; REFERENCES; Chapter 2 -- What Are Current Main Obstacles to Reach Drug Approval?; 1. THE NEED; 2. THE SOLUTION; 3. SWOT; 4. APPLICABLE REGULATIONS; 5. TAKE HOME MESSAGE; REFERENCES; Chapter 3 -- Japan: An Opportunity to Learn?; 1. THE NEED; 2. THE SOLUTION; 3. SWOT; 4. APPLICABLE REGULATIONS. | |
| 505 | 8 | |a 5. TAKE HOME MESSAGE6. CONCLUDING REMARKS; REFERENCES; Chapter 4 -- The "Clinical Trial App"; 1. THE NEED; 2. THE SOLUTION; 3. SWOT; 4. APPLICABLE REGULATIONS; 5. DATA PROTECTION; 6. TAKE HOME MESSAGE; REFERENCES; SECTION 2 -- What Does Our Industry and What Do Others Do; Chapter 5 -- Re-Engineering Clinical Trials: Best Practices for Streamlining the Development Process; 1. THE NEED; 2. THE SOLUTION; 3. RE-ENGINEER TRIALS WITH NEW TECHNOLOGIES AND INNOVATIONS; 4. NEW TECHNOLOGIES; 5. EXISTING AND UNSEEN CHALLENGES; 6. SWOT; 7. APPLICABLE REGULATIONS; 8. TAKE HOME MESSAGE; REFERENCES. | |
| 505 | 8 | |a Chapter 6 -- How Can the Innovative Medicines Initiative Help to Make Medicines Development More Efficient?1. THE NEED; 2. SOLUTION; 3. SWOT; 4. APPLICABLE REGULATIONS; 5. TAKE HOME MESSAGE; REFERENCES; Chapter 7 -- 2E: Experiences with Lean and Shop Floor Management in R & D in Other Non-Pharmaceutical Branches; 1. The Need; 2. THE SOLUTION; 3. SWOT; 4. APPLICABLE REGULATIONS; 5. TAKE HOME MESSAGE; REFERENCES; Chapter 8 -- Failure Mode and Effects Analysis (FMEA): Well-Known Methodologies, But Not in Our World; 1. THE NEED; 2. THE SOLUTION; 3. SWOT; 4. TAKE HOME MESSAGE; 5. APPLICABLE REGULATIONS. | |
| 505 | 8 | |a SECTION 3 -- Where to Start: The ProtocolChapter 9 -- No Patients-No Data: Patient Recruitment in the Twenty-first Century; 1. THE NEED; 2. THE SOLUTION; 3. SWOT: STRENGTHS-PLANNING; 4. SWOT: WEAKNESSES-SITE PERFORMANCE; 5. SWOT: OPPORTUNITIES-THE ENROLLMENT PLAN; 6. SWOT: THREATS-SITES AND REGULATIONS; 7. APPLICABLE REGULATIONS; 8. TAKE HOME MESSAGE; REFERENCES; Chapter 10 -- The Impact of Bad Protocols; 1. A CRITICAL NEED TO ADDRESS RISING PROTOCOL DESIGN COMPLEXITY; 2. IMPACT OF BAD DESIGN ON DIRECT PROCEDURE COSTS; 3. IMPACT OF BAD DESIGN ON STUDY PERFORMANCE. | |
| 505 | 8 | |a 4. THE SOLUTION: OPTIMIZING STUDY DESIGNS5. THE NECESSITY TO OPTIMIZE PROTOCOL DESIGN; 6. TAKE HOME MESSAGE; REFERENCES; Chapter 11 -- Data Mining for Better Protocols; 1. THE NEED; 2. THE SOLUTION; 3. SWOT; 4. APPLICABLE REGULATIONS; 5. TAKE HOME MESSAGE; REFERENCE; Chapter 12 -- It's All in the Literature; 1. THE NEED; 2. THE SOLUTION; 3. APPLICABLE REGULATIONS; 4. TAKE HOME MESSAGE; REFERENCES; Chapter 13 -- What Makes a Good Protocol Better?; 1. THE NEED; 2. THE SOLUTION; 3. TABLE/CHECKLIST; 4. SWOT; 5. APPLICABLE REGULATIONS; 6. TAKE HOME MESSAGE; REFERENCES. | |
| 505 | 8 | |a Chapter 14 -- The Clinical Trial Site. | |
| 504 | |a Includes bibliographical references and index. | ||
| 650 | 0 | |a Drugs |x Testing. | |
| 650 | 0 | |a Drug development |x Safety measures. | |
| 650 | 0 | |a Clinical trials. | |
| 650 | 0 | |a Drug development |x Economic aspects. | |
| 650 | 0 | |a Drugs |x Design. | |
| 650 | 1 | 2 | |a Clinical Trials as Topic |0 (DNLM)D002986 |
| 650 | 2 | 2 | |a Drug Approval |0 (DNLM)D017277 |
| 650 | 2 | 2 | |a Drug Design |0 (DNLM)D015195 |
| 650 | 6 | |a M�edicaments |x Essais cliniques. |0 (CaQQLa)201-0102966 | |
| 650 | 6 | |a M�edicaments |0 (CaQQLa)201-0306620 |x D�eveloppement |0 (CaQQLa)201-0306620 |x S�ecurit�e |0 (CaQQLa)201-0373949 |x Mesures. |0 (CaQQLa)201-0373949 | |
| 650 | 6 | |a �Etudes cliniques. |0 (CaQQLa)201-0070699 | |
| 650 | 6 | |a M�edicaments |0 (CaQQLa)201-0306620 |x D�eveloppement |0 (CaQQLa)201-0306620 |x Aspect �economique. |0 (CaQQLa)201-0374333 | |
| 650 | 6 | |a M�edicaments |x Conception. |0 (CaQQLa)201-0203461 | |
| 650 | 7 | |a MEDICAL |x Pharmacology. |2 bisacsh | |
| 650 | 7 | |a Drugs |x Design |2 fast |0 (OCoLC)fst00898790 | |
| 650 | 7 | |a Clinical trials |2 fast |0 (OCoLC)fst00864429 | |
| 650 | 7 | |a Drugs |x Testing |2 fast |0 (OCoLC)fst00898940 | |
| 700 | 1 | |a Sch�uler, Peter. | |
| 700 | 1 | |a Buckley, Brendan. | |
| 776 | 0 | 8 | |i Print version: |t Re-engineering clinical trials |z 9780124202467 |w (OCoLC)897881150 |
| 856 | 4 | 0 | |u https://sciencedirect.uam.elogim.com/science/book/9780124202467 |z Texto completo |