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市場調查報告書
藥物開發及臨床前階段的安全性預測技術展望
Outlook for Predictive Safety Technologies
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藥物開發及臨床前階段的安全性預測技術展望 是由出版商Insight Pharma Reports在2006年11月所出版的。
這份英文市場調查報告書包含135 pages 價格從美金2750起跳。
於基因調查領域獲得全球性高度評價的美國專業公司 Insight Pharma Reports（總公司：麻州），詳盡地調查與分析安全性預測技術的展望，並出版綜合報告書 "Outlook for Predictive Safety Technologies"。
此報告書除了說明in silico研究、毒物基因體學及高內涵細胞篩選等藥物開發及臨床前階段的安全性預測工具的開發狀況，也提供安全性預測 試驗領域的專家專訪內容等。此報告書的概略架構如下所示。
第1章 說明
- ADME/Tox：安全性評價的基礎
- 提升安全性藥理的潛在領域
第2章 前臨床安全性試驗與藥物開發成本
- 無法預測的毒性
- 複雜的藥物作用與棘手的阻礙
- 研究動物使用範圍的縮小
第3章 對醫藥品安全性的不安
- 相對的醫藥品安全性
- 毒性與副作用
- 安全性預測實驗的目標
- 突變效應與生殖毒性
- 藥物間相互作用與代謝性毒素
- 高通量試驗
第4章 安全性預測工具與技術
- 毒物基因體學
- 高內涵細胞篩選
- 細胞組織學與細胞組織蛋白質體學
- 代謝產物檔案與代謝體學
- 動物樣本
- 針對毒性與發癌性的in silico研究
第5章 新領域
- 案例
- 安全性預測試驗與規範當局
- 「The European Innovative Medicines Initiative」
- 安全性預測試驗研究的資料與展望
第6章 安全性預測試驗領域的專家專訪
用語
企業索引
Abstract
Unexpected toxicity is the single greatest cause of pipeline attrition.
Despite the fact that a typical preclinical safety program will consume about
1,300 rats and 90 dogs, there is no guarantee that the compound will not
present safety problems serious enough to warrant termination. Outlook for
Predictive Safety Technologies, a new CHA Advances report, surveys the
latest developments in discovery-stage and preclinical predictive safety
assessment tools-from in silico methods for lead selection and optimization to
high-content cell-based screens, toxicogenomics, tissue proteomics, and
advanced animal models. It provides the information and analysis you need to
get the best return-in terms of confidence, cost-benefit, and ease of
maintenance and use-on your preclinical safety technology investments.
Specifically, the report delivers:
- A comparative assessment of the leading predictive safety technologies,
with an emphasis on performance, specific applications in non-clinical
testing, and total cost of ownership
- Estimates of potential savings in research costs and animal use-including
a case study scenario of cost savings for a mid-sized biopharma company
- Adoption rates by industry-which technologies are attracting resources,
and why?
- A "virtual roundtable" where 10 leading safety experts in industry and FDA
provide their extended views on key scientific and business issues around
predictive safety technologies
- A quantitative survey (n=46) of the views, practices, and plans of
ADME/Tox researchers in industry and academia presented in easy-to-scan charts
- Expert insight into critical issues such as safety challenges presented by
large molecule drugs, the implications of FDA' s Exploratory IND Guideline, and
timelines to reduced FDA emphasis on animal safety studies
Table of Contents
CHAPTER 1. INTRODUCTION
- 1.1. ADME/Tox: The Cornerstone of Safety Assessments
- 1.2. Areas of Potential for Improvement of Safety Pharmacology
CHAPTER 2. PRECLINICAL SAFETY TESTING AND DRUG DEVELOPMENT COSTS
- 2.1. Unexpected Toxicity: A Constant Source of Attrition to Pharmaceutical
Productivity
- 2.2. Complex Drug Actions Cause Complex Failures
- 2.3. A Savings Scenario for a Mid-Sized Drug Developer
- 2.4. Cutting Back on Research Animal Use
CHAPTER 3. ASPECTS OF DRUG SAFETY CONCERNS
- 3.1. Relative Drug Safety, Not Absolute Toxicity, is the Issue
- 3.2. Toxicity vs. Side Effects
- 3.3. The Objective for Predictive Safety Testing
- 3.4. Mutagenicity and Reproductive Toxicity
- 3.5. Drug-Drug Interactions and "Metabolic Poisoning"
- 3.6. High-Throughput Testing: A Challenge for Predictive Safety Assessments
- 3.7. Knockout Safety Tests with Essentially Unknown Positive Predictive
Value
CHAPTER 4. PREDICTIVE SAFETY TOOLS AND TECHNOLOGIES
- 4.1. Toxicogenomics
- 4.2. High-Content Cell-Based Screening for Safety Parameters
- HCS for General Aspects of Drug Safety
- Rat and Human Hepatocytes
- Cell Models for Modulation of Cardiac Function
- In Vitro Nephrotoxicity Evaluation Using Primary Human Kidney Cells
- HCS for Assessing Hematology Toxicity
- HCS for Genotoxicity Profiling
- Biochips as Solid-State Biosensors for Toxicity and Mutagenicity
- 4.3. Tissue Histology and Tissue Proteomics: Creating Powerful New Tools
from Old Ones
- Pioneering Efforts in Histopathology
- NeuroScience Associates
- HistoRX
- Phase I Molecular Toxicology
- 4.4. Metabolite Profiling and Metabonomics As a Tool for Toxicity
Prediction
- Metabolite Profiling
- Predicting Drug Interactions from In Vitro Metabolic Data
- Predicting Cytochrome P450 Interactions and Inhibition
- Pharmaco-Metabolomics
- 4.5. Animal Models
- The Zebrafish: An Intriguing Vertebrate Model for Toxicity Testing
- Rodents Tailored for Predictive Toxicology
- Isogenic Rat Panels
- Mice Under Realistic Stress Conditions
- Transgenic Animals for Carcinogenicity Testing
- Unconventional Animal Models
- 4.6. In Silico Approaches to Toxicity and Carcinogenicity
- The ToxML Format: A Platform for Toxicity Data Exchange
- Structure-Based Prediction of Hepatotoxicity
- In Silico Identification of Compounds at Risk for Inducing Cardiac
Arrythmia
- Other In Silico Toxicity Prediction Models
- Commercial Software Packages and Services
CHAPTER 5. SAFETY SIGNALS FOR BIOTECH DRUG CANDIDATES: AN EMERGING FIELD
- 5.1. Cases in Point
- 5.2. Predictive Safety Testing and Regulatory Authorities
- The Predictive Safety Testing Consortium: A Spin-Off from the Critical
Path Initiative
- Voluntary Genomics Data Submissions: An Exercise for the Future
- The FDA' s Intramural Biomarker Program
- 5.3. The European Innovative Medicines Initiative
- 5.4. A Synopsis of Facts and Perspectives for Predictive Safety Testing
Approaches
CHAPTER 6. INTERIVEWS WITH EXPERTS IN THE PREDICTIVE SAFETY TESTING FIELD
- Felix W. Frueh, PhD, US Food and Drug Administration
- Joseph F. Contrera, PhD, US Food and Drug Administration
- Donald Halbert, PhD, Iconix Biosciences
- D. Lansing Taylor, PhD, Cellumen
- Michael Milburn, PhD, Metabolon
- Patricia McGrath, MBA, Phylonix
- Paul Stroobant, PhD, HistoRx
- Peter-Jan van Doorn, MD, MBA, MDS Pharma Services
- Manfred Windisch, PhD, JSW Research
Glossary
Company Index with Web Addresses
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