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View our catalog of publications, articles, white papers, webinars and more.
Publications and Articles
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CMS Reimbursement Coverage in Wound Care: Adapt or Be Left Behind
October 8, 2024
Key Takeaways from SAWC Fall 2024
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Leveraging ODS RTF Techniques for Effective Tables and Listings in Clinical Reporting
September 9, 2024
The Output Delivery System (ODS) in SAS is a powerful feature that enables users to generate output in various file formats, making it increasingly popular in clinical reporting. The ODS within SAS offers a versatile range of file formats, including RTF, HTML, and PDF, each providing unique benefits for data presentation.
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Using Estimand Frameworks in Clinical Trials
September 9, 2024
In clinical trials, the primary goal is to evaluate the efficacy or safety of a treatment within a specific patient population. However, traditional statistical methods often fall short when unexpected events occur, which can lead to ambiguity in result interpretation. This is where the estimand framework, as outlined in the ICH E9(R1) addendum, steps in to offer a systematic approach to defining treatment effects that ensures clarity and consistency throughout the trial process.
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Navigating the New Medicare Policy for HCT/Ps in Wound Care
August 13, 2024
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One Year of Regulatory Training Abroad: Korean MFDS Staffer Working at U.S. CRO Shares Her Experience
September 8, 2020
The Korean Ministry of Food and Drug Safety (MFDS) has a number of international cooperation programs designed to help key staff better understand global medical product development practices.
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Mortality and Long-Term Functional Outcome Associated With Intracranial Pressure After Traumatic Brain Injury
August 3, 2012
We have examined whether raised elevated intracranial pressure (ICP) is independently associated with mortality, functional status and neuropsychological functioning in adult traumatic brain injury patients.
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Craniofacial Variables in Subjects With and Without Habitual Snoring: A Cephalometric Comparison
September 1, 2010
The aim of this case control study was to evaluate which cephalometric variables related to craniofacial morphology discriminate between snoring and non-snoring or any other respiratory disease subjects.
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Evaluation of 278 Hla-b27 Positive Patients Suspected of Seronegative Spondyloarthropathies
October 1, 2007
To determine HLA-B27 prevalence in patients suspected of Seronegative spondyloarthropathy referred to the Transplantation Department of Blood Transfusion Organization, and to evaluate clinical findings among HLA-B27 positive patients.
White Papers: Biostatistics
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Understanding the Misinterpretation of P-Values in Statistical Analysis
August 15, 2024
In contemporary research, the misinterpretation of p-values has become a prevalent issue, leading to flawed conclusions and misconceptions. The p-value, a crucial statistical measure, is frequently misunderstood and misused, undermining the integrity and validity of research findings.
About Amarex
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Frequently Asked Questions
August 8, 2024
White Papers: Regulatory Affairs
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Designing — and Planning — for an Accelerated FDA Review
September 27, 2022
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Expertise and Communication Support for Complex Innovative Trial Design (CID) Success
June 10, 2022
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SOPs: Least Understood, Most Important Tool to Ensure Regulatory Compliance
October 4, 2011
Learn the most common issues with SOP creation, management and implementation and solutions.
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Resolving Scientific Disputes With FDA: Regulatory Processes and Practical Tips
March 1, 2011
Learn the processes for initiating an appeal, escalating a dispute and dealing effectively with the FDA.
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Meeting With FDA Can Increase the Probability of Product Approval
October 1, 2010
Formal meetings with reviewers at the U.S. Food and Drug Administration (FDA) are among the most important and useful resources available to sponsors of medicinal products seeking marketing approval in the U.S.
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Biosimilars: Past, Present and Future
April 13, 2010
Learn the regulatory history, new proposed development pathways, realities and myths about biosimilars, the politics involved and what the future holds.
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The 505(b)(2) Drug Development Pathway: When and How to Take Advantage of a Unique American Regulatory Pathway
April 6, 2010
The 505(b)(2) regulation offers a less expensive and faster new drug development pathway that may be particularly attractive to a manufacturer with experience in developing generic products.
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Forecasting for Success: The Power of Regulatory Gap Analysis
December 1, 2008
A gap analysis is a powerful tool that can be used to forecast a particular product’s success.
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Considering Outsourcing? Risks and Benefits for FDA-Regulated Firms
October 14, 2008
Learn the four keys to an effective outsourcing strategy.
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The Promise of Biogenerics: Hope and Hype
January 8, 2008
Generic biologics hold great promise. It is inevitable that regulations for biosimilars or follow-on biologics will be implemented in the near future.
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Regulatory Considerations for Conducting Clinical Trials in India
March 26, 2007
Learn the history of Indian drug regulations, current regulatory processes and practical issues in outsourcing drug discovery and clinical development programs to Asia, particularly India.
Other Resources
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Oncology Clinical Trials: An Emerging Paradigm Shift in Study Design
April 27, 2022
This white paper explains the different study designs for clinical trials and the emergence of master protocols as a way to simultaneously evaluate multiple drugs and/or disease populations in multiple studies. Find out the key features of master protocol trial designs, including the practical and statistical challenges associated with designs of this type.
White Papers: Development Strategy
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Beyond a Requirement: The Value of Highlighting Postmarketing Safety Efforts
October 20, 2021
PMS plan helps refine future trials for better direct drug discovery efforts and required prior to reaching market approval from regulatory agencies like FDA.
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Understanding Adaptive Designs for Clinical Trials
April 21, 2020
This white paper provides an overview of adaptive design in clinical trials, including its history and current application in the pharmaceutical and biotech industry.
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Risks and Benefits of Conducting Preclinical Studies in the Global Setting
December 20, 2011
It is generally accepted that the preclinical studies needed for first-in-man clinical studies usually take one to three years and cost up to $10 million USD.
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Global Development of an Innovative Medical Device for the U.S. Market
December 13, 2011
Creating a new medical device based on new technology is a daunting task.
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Development of Wound Management Products for the U.S.
December 6, 2011
Wound care products are primarily aimed at ensuring timely wound healing and effective infection control.
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Strategies for Implementing the New GMPs for Dietary Supplements
February 8, 2011
In the last few years, there has been increasing interest in the pharmaceutical industry in outsourcing drug discovery and clinical development programs to Asia, particularly India.
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Developing Botanical Products from India for the U.S. Market
August 4, 2009
With only 10% of the Earth’s estimated 250,000 species of plants considered medicinal, botanicals are the “sleeping giant” of drug development.
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Developing Traditional Chinese Medicines as Botanical Drugs for the U.S. Market
August 1, 2009
Therapeutic products derived from medicinal plants have been used throughout the history of mankind.
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Regulatory Harmonization Efforts in India: Keeping in Step With the Globe
June 10, 2008
The Indian pharmaceutical industry has established itself as a key player in the manufacturing arena, with almost half of the active pharmaceutical ingredients (APIs) worldwide being produced there.
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Designing a Global Product Development Strategy
June 3, 2008
Pharmaceutical products are truly global in nature—not only in terms of usage but also in terms of the strategic location of different development activities.
Assessments
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Are you ready to submit your IND/IDE application to the FDA?
August 5, 2021
Webinars
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Oncology Clinical Trials: An Emerging Paradigm Shift in Trial Design
October 27, 2020
This webinar reviews several newer clinical trial strategies such as combining adaptive trial designs with innovative endpoints.
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Upgrading the FDA Adverse Event Reporting System (FAERS) Based on ICH E2B (R3) Standards
April 7, 2020
Shide Badri, M.D., summarizes upgrades to electronic submission of individual case safety reports in FAERS, FAERSII’s implementation timeline, and benefits and impacts.
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