Navigation Links
Companion Diagnostics in Personalized Medicine and Cancer Therapy
Date:8/6/2014

/>Appendix 1: FDA Guidance for Industry: Pharmacogenomic Data Submissions 265
Appendix 1.1: Introduction 265
Appendix 1.2: Background 265
Appendix 1.3: Submission Policy 266
Appendix 1.3.1: General Principles 266
Appendix 1.3.2: Specific Uses of Pharmacogenomic Data in Drug Development and Labeling 268
Appendix 1.3.3: Benefits of Voluntary Submissions to Sponsors and FDA 269
Appendix 1.4: Submission of Pharmacogenomic Data 269
Appendix 1.4.1: Submission of Pharmacogenomic Data During the IND Phase 270
Appendix 1.4.2: Submission of Pharmacogenomic Data to a New NDA, BLA or Supplement 271
Appendix 1.4.3: Submission to a Previously Approved NDA or BLA 272
Appendix 1.4.4: Compliance with 21 CFR Part 58 272
Appendix 1.4.5: Submission of Voluntary Genomic Data from Application-Independent Research 272
Appendix 1.5: Format and Content of a VGDS 273
Appendix 1.6: Process for Submitting Pharmacogenomic Data 274
Appendix 1.7: Agency Review of VGDSs 274
Appendix 2: FDA Issues Draft Companion Diagnostic Guidance 276
Appendix 3: Histochemical Markers for Cancer 278
Appendix 4: E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions 279

Appendix 4.1: Introduction 279
Appendix 4.2: Background 279
Appendix 4.3: Scope 279
Appendix 4.4: General Principles 279
Appendix 4.5: Structure of Biomarker Qualification Submissions 280
Appendix 5: Selected Personalized Medicine Drugs, Treatments and Diagnostics as of June 2014 287
Glossary 292


INDEX OF FIGURES

Figure 2.1: Strategic and Tactical Considerations for Co-Development of Companion Diagnostics 24
Figure 2.2: Global Market for Companion Diagnostics, 2012-2019 25
Figure 2.3: Number of Companion Diagnostic Agreements, 2000-2013 26
Figure 2.4: Surface Binding Produces Phase Shifts that Increases the Diffraction Signal Intensity 36'/>"/>

SOURCE ReportBuyer
Copyright©2014 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13

Related medicine technology :

1. Ventana paves the way for companion diagnostic early phase clinical trials in China to advance patient care
2. QIAGEN and AstraZeneca Collaborate to Develop Liquid Biopsy-Based Companion Diagnostic to Advance EGFR Mutation Profiling in Lung Cancer Patients
3. Ventana Medical Systems, Inc. and Merck KGaA, Darmstadt, Germany to develop companion diagnostic test for cancer treatment
4. Ventana announces HER2 companion diagnostic to identify breast cancer patients for Roches latest targeted medicines, Perjeta and Kadcyla
5. Ventana to partner with Incyte on the development of Companion Diagnostic tests
6. Kennel Cough is in Season all Year for our Canine Companions
7. Harrisvaccines, Inc. Secures Exclusive Rights From AlphaVax, Inc. to Develop RNA Particle Vaccines for All Diseases in Companion Animals
8. Ventana receives approval from Chinas FDA for first fully automated IHC companion diagnostic identifying ALK protein expression in lung cancer patients
9. Companion Diagnostics Market Report - Streamlining Drug Development and Advancing Personalized Medicine
10. Companion Diagnostics Market, 2012-2023
11. Companion 2 Hospital Driver for Powering SynCardia Total Artificial Heart Wins Silver at Medical Design Excellence Awards
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/19/2014)... , Oct. 19, 2014  Henry Schein, Inc. ... of health care products and services to office-based dental, ... has invested in Iwase Dental Supply, Inc., a leading ... Japan.  The transaction marks Henry Schein,s entrance into ... dental market, and increases to 28 the number of ...
(Date:10/17/2014)... , Oct. 17, 2014  Hanger, Inc. (NYSE: ... report its results of operations for the quarter ended ... the market closes.  A conference call to discuss these ... on Friday, November 7, 2014. Those wishing to participate ... Friday, November 14, 2014 by dialing 1-855-859-2056 and referencing ...
(Date:10/17/2014)... , October 17, 2014 ... report "Optical Imaging Market by Technique (Optical Coherence ... Imaging software) & by Application (Ophthalmology, Neurology, Oncology, Cardiology) ... MarketsandMarkets, this report studies the Optical Imaging market ... market was valued at $917.1 million in ...
Breaking Medicine Technology:Henry Schein Enters Japan With Investment in Iwase Dental Supply 2Henry Schein Enters Japan With Investment in Iwase Dental Supply 3Henry Schein Enters Japan With Investment in Iwase Dental Supply 4Henry Schein Enters Japan With Investment in Iwase Dental Supply 5Optical Imaging Market Worth $1,669.2 Million by 2019 2Optical Imaging Market Worth $1,669.2 Million by 2019 3Optical Imaging Market Worth $1,669.2 Million by 2019 4
(Date:10/20/2014)... 2014 Do you ever feel difficulty ... a wonderful app Metassessor for teachers, specialists and parents. ... helped its client “Intervention Development LLC” to launch Metassessor ... designed for iOS 4.3 or later and is Compatible ... optimized for iPhone 5. It is now available on ...
(Date:10/19/2014)... Recently, BambooIndustry.com, one of the most popular suppliers ... bamboo deckings . Moreover, the company has launched ... now available at deeply discounted rates. , As ... overstate the significance of online business nowadays. Thus, BambooIndustry.com ... company’s workers are striving to deliver both value and ...
(Date:10/19/2014)... Having been working in the garment industry for ... needs. According to James, one of the company’s top designers, ... with high-low skirts that add beauty to them. Chiffon floor ... has unveiled its new selection of 2014 long prom dresses. ... new items are available in over 20 popular designs. The ...
(Date:10/19/2014)... October 20, 2014 SweetDressy.com, a professional ... announced its promotion for long evening dresses . ... the special offer; the current discount is up to ... the industry pioneers in the fashion field. Its dress ... ladies dwelling in various parts of the world. All ...
(Date:10/19/2014)... 19, 2014 (HealthDay News) -- New stem cell-based research ... to new treatments, a new study suggests. Scientists ... intestinal tissue in a lab dish. They then transplanted ... studying intestinal disorders, according to the researchers. "This ... and conditions that can cause intestinal failure, from genetic ...
Breaking Medicine News(10 mins):Health News:Metassessor App Launched: an RTI tool for Teachers & Parents 2Health News:Metassessor App Launched: an RTI tool for Teachers & Parents 3Health News:High Quality Bamboo Deckings, New Items Unveiled By BambooIndustry.com 2Health News:2014 Long Prom Dresses From LunaDress Now Available In Over 20 Popular Designs 2Health News:Promotion For Beautiful Long Evening Dresses Launched By SweetDressy.com 2Health News:Scientists Grow, Implant Human Intestinal Tissue in Mice 2
... , , COLLEGEVILLE, ... (NYSE: WYE ), announced the publication of data ... Vaginal Cream 0.5 g to relieve some of the bothersome ... (dyspareunia). This study evaluated the efficacy of two low-dose regimens ...
... Amsterdam, 13 July 2009 Elsevier announced today the ... research tool developed in collaboration with the Allen Institute ... George Paxinos and Charles Watson, Prince of Wales Medical ... the Society for Neuroscience,s Neuroscience 2008 tradeshow last November, ...
... Long term care costs in Colorado continue to rise ... those in or near retirement. As a leader in the ... insurance products to help people proactively plan for their future. ... of a new program designed to simplify the process of ...
... SAN FRANCISCO, July 13 Following months of ... what it believes to be a very solid patent ... CEO Edwin Marshall stated, "This U.S. priority patent application ... Internationally. We had two different firms specializing in ...
... expensive clozapine might have saved thousands of lives, researchers ... Thousands of schizophrenia patients worldwide may have died because ... second-generation antipsychotic drug clozapine, a new study suggests. , ... lower death rate compared to other antipsychotics. , For ...
... Germany, July 13 Miltenyi Biotec is,proud to announce ... -196 degreesC), storage, and thawing (at 37 degreesC) of ... to meet customers,requirements and to exceed current standards for ... ) , Each freezing ...
Cached Medicine News:Health News:Study Evaluating Efficacy and Safety of Two Low-dose Regimens of PREMARIN Vaginal Cream for the Treatment of Moderate to Severe Vaginal Atrophy Now Published 2Health News:Study Evaluating Efficacy and Safety of Two Low-dose Regimens of PREMARIN Vaginal Cream for the Treatment of Moderate to Severe Vaginal Atrophy Now Published 3Health News:Study Evaluating Efficacy and Safety of Two Low-dose Regimens of PREMARIN Vaginal Cream for the Treatment of Moderate to Severe Vaginal Atrophy Now Published 4Health News:Study Evaluating Efficacy and Safety of Two Low-dose Regimens of PREMARIN Vaginal Cream for the Treatment of Moderate to Severe Vaginal Atrophy Now Published 5Health News:Study Evaluating Efficacy and Safety of Two Low-dose Regimens of PREMARIN Vaginal Cream for the Treatment of Moderate to Severe Vaginal Atrophy Now Published 6Health News:Elsevier launches official version of BrainNavigator 2Health News:Genworth Financial Simplifies the Process of Purchasing Affordable Long Term Care Insurance for Colorado AARP Members 2Health News:Genworth Financial Simplifies the Process of Purchasing Affordable Long Term Care Insurance for Colorado AARP Members 3Health News:Genworth Financial Simplifies the Process of Purchasing Affordable Long Term Care Insurance for Colorado AARP Members 4Health News:Genworth Financial Simplifies the Process of Purchasing Affordable Long Term Care Insurance for Colorado AARP Members 5Health News:Medizone International, Inc. Has Filed for Patent Protection for Its AsepticSure(TM) Hospital Sterilization System 2Health News:Schizophrenia Drug Got Bad Rap 2Health News:Advanced Bag Design for Cryopreservation: The New CryoMACS(R) Freezing Bag 2
Full Handle Laseredge Implant Blade Knife, 4.0 mm straight. Blade dimension: 15.2 mm x 4.0 mm x 3.0 mm x 1.6 mm....
Full Handle Laseredge Crescent Blade Knife, angled double bevel. Blade tip dimension: 12.7 mm x 2.0 mm x 3.8 mm....
Full Handle Laseredge Crescent Blade Knife, angled bevel up. Blade tip dimension: 12.7 mm x 2.0 mm x 3.8 mm....
Full Handle Laseredge Stab Blade Knife, 45 blade. Blade tip dimension: 8.9 mm x 1.9 mm x 1.9 mm....
Medicine Products: