Wednesday, July 8, 2009

SAS® Product Drug Development Used in Healthcare

Drug Discovery and Development with SAS®
SAS provides a centralized, integrated solution for managing, analyzing, reporting and reviewing clinical research information. This solution enables life sciences organizations to make informed business decisions with confidence, to assess the safety and efficacy of research compounds more effectively, to collaborate across trials, phases and therapeutic areas successfully, and ultimately get better products to market faster.
Available Drug Discovery and Development Solutions from SAS:
SAS Drug Development provides an analysis and reporting solution that enables global collaboration with complete compliance and control. SAS OnDemand: Drug Development offers small and midsize businesses a centralized, controlled, Web-based solution for efficiently developing, executing and managing the transformation, analysis and submission of clinical research data.
SAS® Drug Development:
SAS Drug Development enables the collation and sharing of clinical research data throughout the entire organization via a well-managed, controlled, centralized repository. This single version of the truth enables rapid, efficient sharing of resources, data and knowledge across trials, phases and therapeutic areas at all stages of the clinical R&D process.
Benefits:
A single version of the truth. SAS Drug Development delivers full data integration and standardization via a centralized information repository that gives researchers throughout the organization direct access to both the research content and embedded intelligence tools at all stages of the clinical R&D process.
Full compliance with industry standards. SAS Drug Development provides the ability to meet industry expectations for managing research information content in accordance with government regulations, including 21 CFR Part 11, good industry practices (GxP) and sound business practices.
Automated integrity, traceability and transparency. The degree of transparency and traceability of all data analysis activities provided by the solution ensures ongoing quality control and quality assurance, and makes it easy to confidently address inquiries from regulatory agencies. More confidence in research decisions. Researchers can easily review multiple data sources to analyze research across trials, phases and therapeutic areas. This comprehensive view makes it easier to make go/no-go research program decisions earlier in the process.
Shorter development cycles. With the ability to make more confident decisions and analyze data from a single repository, researchers can reduce the time spent searching for, gathering and aggregating data for analysis. The solution also helps streamline and automate research and analysis tasks.
Download the complete SAS Drug Development Fact Sheet
How SAS Is Different
  • A standardized, centralized repository. SAS Drug Development integrates data from all relevant sources, stores all information related to a clinical research program, and brings this information together in a standardized, centralized repository.
  • Streamlined processes. By providing immediate access and ongoing insight into project progress, SAS Drug Development gives organizations better control over the deployment of resources, as well as the streamlining of clinical R&D processes and tasks.
  • Integrated SAS® program development and execution. An embedded program development environment provides the ability to easily develop SAS programs and macro libraries, review log files and test program functionality.
  • A truly collaborative environment. Research scientists and less technical users have direct access to research data, statistical results and all other relevant clinical research content via a secure, user-friendly interface.
  • Full compliance. SAS Drug Development was carefully designed to meet existing and emerging government regulations, including 21 CFR Part 11, as well as good industry practices and sound business methodologies.

Only SAS provides a secure, collaborative framework that puts controlled power into the hands of researchers who need it. The result is greater productivity and efficiency in these areas:

  • Integration. Efficiently integrate and manage data from a wide range of sources – such as electronic data capture (EDC) systems, in-house clinical data management systems (CDMS), labs and contract research organizations (CROs) – while leveraging investments in existing systems and resources.
  • Analysis and reporting. Accurately assess and report on study data in a timely manner. Efficiently generate presentation-ready statistical summaries of clinical trials data and easily share results with researchers or reviewers on demand.
  • Discovery. Use your growing research information repository to rapidly investigate critical drug safety issues, pursue new marketing claims and explore potential product-line extensions.
  • Regulatory compliance. Document research content via integrated processes that provide versioning, audit trails and electronic signatures, as well as fully describing the relationships between all process inputs, transformations, analyses and results.

Note: The matter has been taken from the SAS® Site

Wednesday, July 1, 2009

WinNonlin® 6.0

Phoenix™ WinNonlin® 6.0 — Next Generation of the Industry Standard for PK/PD Modeling and NCA

Phoenix WinNonlin improves scientific productivity during critical drug development tasks by providing a comprehensive analysis environment that implements efficient reusable workflows and high quality outputs while reducing barriers to learning and collaboration, enabling more impactful quantitative decision making.
Phoenix WinNonlin 6.0 offers the following benefits:
  • Comprehensive Analysis Environment: Perform virtually all of the analyses for standard PK and PK/PD studies. MORE
  • Efficient Workflow Management: Create, reuse, and share analyses as stored workflows. Easily process, visualize, and tabulate data while allowing the flexibility to edit in Excel. MORE
  • High Quality Outputs: Generate high-quality graphs, tables, and figures allowing for integrated communication of analysis results. MORE
  • Easy to Learn and Share: Minimize the amount of time spent learning the software and promote collaboration through easily transferable project files, workflows, and templates. MORE
  • Enables Compliance: Provide technical controls for 21 CFR Part 11 compliance when used in conjunction with Pharsight Knowledgebase Server™. MORE

Phoenix™ WinNonlin® Features

Key features of Phoenix WinNonlin include the following:

  • Comprehensive Analysis Environment

Perform noncompartmental analysis of both blood and urine data using methods for rich or sparse datasets in a single run.

Three methods of AUC calculation: linear trapezoidal, linear/log trapezoidal, and linear up/log down.

Descriptive statistics, including weighted descriptive statistics.

Units definition and conversions, including the ability to specify preferred output units, units for a dosing regimen, and unit conversions.

Powerful data management tools allow users to append worksheets, change properties and/or transform columns, add BQL Rules or map cross product worksheets, as well as filter, join, merge, pivot, rank, split, and stack data.

Toolbox functions for deconvolution, semicompartmental modeling, nonparametric superposition and crossover design.

Automatic determination of initial estimates.

Analysis using general linear modeling approaches, including bioequivalence tests as appropriate.

Built-in scripting language (Pharsight Modeling Language or PML).

  • Efficient Workflow Management

Workflow management tools that enable users to create, reuse, and share models and projects.

More powerful data management tools. Excel compatible workbooks, including formulas, functions, data import/export, missing value codes, sort, transformations and worksheet merge.

Insert favorite workflow components and/or sub-workflows into larger workflow diagrams.
Easily map data inputs to multiple models.

  • High Quality Outputs

Significantly improved, report-ready graphs, plots, tables and listings greatly reduce the reliance on external graphics software.

Easily insert bar, column, and box plots; histograms; XY, QQ plots, and/or scatter plot matrices into your workflows.

Easily change the formatting of any plot to suit reporting requirements.

One-click export of results, plots, and tables to Microsoft Excel® or Word®, SAS, graphic files, or text.

  • Easy to Learn and Share

An intuitive user interface provides multiple click-paths to accomplish the same tasks, allowing users to use the software in ways that make suit their personal preferences.

All data, models, scripts, tables, BQL rules, documents, models, workflows, plots, graphs, and outputs are contained in one project file that can easily be shared.

Classroom and online training courses will be offered regularly to support new users.

  • Enables Compliance

Every workflow object has a 'Verification' tab that explains whether the object executed properly and any errors that may have occurred.

Full integration with the Pharsight Knowledgebase Server™ (PKS™) data repository enabling all changes to projects to be logged in the PKS database

Validation can be speeded up significantly with the Phoenix Validation Suite™

Note: If anything needed please see the below link-

http://www.pharsight.com/products/prod_phoenix_winnonlin_feature.php

Shire selects SAS® Drug Development to Handle Clinical Trials Data

CARY, NC (Jun. 22, 2009) – SAS, the leader in business analytics, today announced that Shire, the global specialty biopharmaceutical company, has selected SAS® Drug Development as the platform for its clinical trials data.

“Shire is excited about our partnership with SAS, and we look forward to leveraging the SAS Drug Development platform to manage our clinical trial data,” said Nick Ronca, Associate Director Clinical R&D, Shire Pharmaceuticals.

SAS Drug Development is available as a standalone or hosted solution with access via a secure, thin client. A centralized repository allows life sciences firms to aggregate, analyze and review clinical trials data to determine safety and efficacy outcomes.

“Our approach at SAS allows our customers, like Shire, to be more focused and efficient in developing and delivering medicines to patients and their families around the world,” said Jason Burke, Global Director of Health and Life Sciences for SAS.

21 CFR and CDISC Compliant
SAS Drug Development allows rapid and reliable validation and implementation, eliminating strain on limited IT infrastructure and resources. The solution is compliant with global agency regulations, such as 21 CFR Part 11, which is often difficult to attain.

“Our hosted global environment contains a single view of the targeted clinical data in a secured and qualified environment so scientists, programmers and statisticians can view the most up-to-date, accurate information” said Burke.

SAS’ scalability and flexibility were features important to Shire, which has grown rapidly through acquisitions and mergers over its nearly twenty-five year history. Shire, which has a presence in 23 countries and markets medicines in more than 45 countries, needed a global solution for managing and processing its clinical trial data.

“Working in unison with SAS allows Shire to focus on meeting its mission, and investing in its product portfolio instead of developing a complex IT infrastructure to support clinical data,” said Burke.

SAS Implementation Team
Relying on the SAS Consulting Group that has successfully deployed SAS Drug Development in the past, Shire believes that the system will maximize the best practices of both Shire and SAS. SAS is demonstrating SAS Drug Development at the DIA 45th Annual Meeting in Booth 301.

About SAS SAS is the leader in business analytics software and services, and the largest independent vendor in the business intelligence market. Through innovative solutions delivered within an integrated framework, SAS helps customers at more than 45,000 sites improve performance and deliver value by making better decisions faster. Since 1976 SAS has been giving customers around the world The Power to Know® .

PG Diploma in Biostatistics

Madurai Kamaraj University - Directorate of Distance Education

Madurai Kamaraj University is a Statutory University, established in 1966 by Govt. of Tamilnadu. It is recognized and funded by UGC and is a member of Association of Indian Universities. It has been reaccredited by NAAC with grade A.The Directorate of Distance Education of this university was established in 1971 and has a student strength of about 1.20 lakhs. There are 38 Spot Admission Centres and 85 Study Centres outside Tamilnadu across the country and 12 Study Centres outside the country. Recently this University was accorded the status of "University with Potential for Excellence" - A status conferred by University Grants Commission so far on 9 such Universities in the Country. The home site for this is
Recognized by Distance Education Council (DEC), New Delhi Eligible for Central & State Govt. Employment
The following Link is for the different Post Graduate Diploma Courses

http://www.mkudde.org/courses_pgdip.php

Indian Institute of Public Health—Hyderabad, Summer Institution Program

Indian Institute of Public Health



A year long Post Graduate Diploma in Biostatistics and Data Management was launched in August, 2008 at IIPH-Hyderabad. This course was designed to equip students with modern tools of data management and applied biostatistics, in order to qualitatively enhance the skills of practicing biostatisticians and epidemiologists in the areas of medical research and public health. The target audience for this course includes public and private sector organizations, academicians and researchers in public health, medical colleges, hospitals, contract and clinical research organizations and pharmaceutical agencies, those engaged in national public health programmes initiated by the Government of India and research institutions.




Course
Post Graduate Diploma in Biostatistics and Data Management can be downloaded from below link

http://www.phfi.org/downloads/pdf/Post%20Graduate%20Diploma%20in%20Biostatistics%20and%20Data%20Management.pdf



Application Form- PGDBDM can be downloaded from below link

http://www.phfi.org/downloads/pdf/Application%20Form%20-%20PGDBDM.pdf



Poster - PGDPBDM can be downloaded from below link



http://www.phfi.org/downloads/pdf/Poster_Biostatistics.pdf





The Indian Institute of Public Health—Hyderabad, Summer Institution (June-July, 2009)details / Catalog/ are can be downloaded from the following Link:



http://www.phfi.org/downloads/pdf/IIPH-Hyderabad%20Summer%20Institue%20(June-July%202009)%20Course%20Catalog.pdf