Rules-Based Medicine Rules-Based Medicine (RBM) is a CLIA-certified biomarker testing laboratory specializing in cost-effective, high-quality multiplexing services. Our protein immunoassays benefit drug discovery & development from...
The Jackson Laboratory We help researchers discover treatments, preventions and cures for human disease through the provision of inbred, mutant and genetically engineered mouse models, research services, and comprehensive technical information...
Beckloff Associates Founded in 1976, Beckloff Associates, Inc. assists companies with worldwide development of pharmaceutical, biotechnology, and medical device products through regulatory and product development planning, regulatory...
Marketing Authorization Application Services
MAASupport services: Includes strategic regulatory strategy, document preparation, regulatory publishing, pre- and post-approval maintenance, launch...
NDA Preparation Services
NDA Support services: Includes strategic regulatory strategy, document preparation, regulatory publishing, pre- and post-approval maintenance, launch...
First Data Bank At First DataBank, a dedication to quality and patient safety underlies everything we do. We understand both the human cost of medication errors and the fact that our drug information can play a significant role in their...
AHFS DRUG INFORMATION MONOGRAPHS
As an in-depth electronic reference, American Hospital Formulary Service® Drug Information (AHFS DI) from the American Society of Health-System...
AHFS FRAMEWORK
Today more than ever, healthcare professionals need convenient access to drug information from within their clinical decision-support systems. Using current...
DRUG INFORMATION FRAMEWORK
Time to market can be critical to the success of your next- generation drug information products. Yet you're working under difficult constraints, such as...
Relsys International Inc. Relsys is the acknowledged market leader in the area of drug safety and regulatory affairs, providing our customers with one-stop solutions for:
* Global Regulatory Compliance
* Operational Excellence and...
Kerdan Group We are a boutique strategy consulting firm based out of Kendall Square, the biotech center of Cambridge, MA. We work with cross-functional biopharma development and disease area teams to drive a creative strategic process...
SemBioSys. SemBioSys Genetics Inc. is a plant biotechnology company with a powerful technology that enables production of high-value pharmaceutical and non-pharmaceutical products in an affordable and sustainable manner. At...
Cardiovascular Disease
Cardiovascular diseases, including heart attack and stroke, are the leading causes of mortality in developed nations and by 2010, are projected to become...
Conducting comprehensive metabolism studies has long been an essential component of a preclinical drug development program. However, numerous factors — including the increased development of protein-derived drugs and the expanded interest in the role of metabolites in safety assessment — are having a significant impact on the regulatory mandates, scope of studies and methodologies employed. In ...
Prediction of the absorption, distribution, metabolism, excretion, and toxicity (ADMET) properties of compounds in pharmaceutical development are essential aspects of the drug discovery process. B-CLEAR® (sandwich-cultured hepatocytes) is an in vitro system that is used to analyze and predict the in vivo hepatobiliary disposition (hepatic uptake, biliary excretion, and biliary clearance) and ...
In recent years the pharmaceutical industry has declined in performance (1), with replenishment of the product pipeline becoming the main criterion for drug discovery research transformation. With US$ 60bn worth of products going off patent by 2011, life science companies must identify novel and innovative methods to compensate for falling research productivity (2). According to Jean-Pierre ...
The last decade has seen rapid technological progress but with increasing demands for safe and efficacious drugs, technological solutions that reduce the barriers to clinical success will be of more interest than those that simply shift the bottlenecks and necessitate new compromises in the discovery and development process.
Presently, pharmaceutical companies are adopting targeted and rational drug discovery route. Traditional novel drug discovery programs were essentially based on the screening of a library of chemical compounds developed by a combinatorial chemistry approach. For this, a target protein molecule was essential for designing a drug. Only a small number of specific drug targets were available earlier. ...
FDA issued a guidance document entitled “Adverse Reactions Section Labeling for Human Prescription Drug and Biological Products – Content and Format” in January 2006. The guidance is intended to assist both applicants and reviewers draft the Adverse Reactions section of the prescribing information in the new format specified by the labeling rule finalized in January 2006 and effective June 2006. ...
Fulfilling the promise of medicine together
Fundamentals in Drug Safety Strategies John McLane, Ph.D. Clinquest, Inc.
Risk and Benefit management processes have become exceedingly complex in today's drug development environment. Starting from the preclinical assessments to the full Risk Evaluation and Mitigation Strategies (REMS) for the Safe Use of pharmaceutical products, risk management has ...
The U.S. Orphan Drug Act was signed into law in 1983 and for the first time, provided incentives for the pharmaceutical industry to develop drugs that otherwise had minimal commercial return on investment, but which are necessary, and often life-saving, for patients with rare diseases. The Orphan Drug Act is codified in 21 CFR Part 316.
There are approximately 6000 rare disorders affecting ...
A crucial element in the development of topical and transdermal drug products is evaluation of the percutaneous absorption of the active pharmaceutical ingredient (API). Generally, the goal for topical products is to maximize cutaneous delivery of the API, whereas for transdermal products the goal is to achieve a specific rate of absorption sufficient to achieve a systemic blood level within the ...
United States federal laws make mandatory the registration of drug establishments, including both domestic and foreign, and the submission of drug listing information to FDA. Discover the details of the mandatory regulations requiring drug establishment registration and drug listing information to be submitted electronically.
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