Drug Safety
The Lead
Tracking Human Metabolism with Carbon-14
February 14, 2013 1:39 pm | by Sean L. Kitson, PhD, Investigator of Radiochemistry, Department of Biocatalysis and Radiolabeling; Almac; Craigavon, U.K. | Articles | Comments
A drug entering the body undergoes a series of biotransformations via phase I and phase II metabolic pathways. The metabolites produced have a similar chemical structure to the parent drug and are more pharmacologically active at the therapeutic receptor sites.
Pharmacometric Modeling to Support Pediatric Clinical Trials
October 5, 2012 4:17 pm | by Charlene Sanders, MD, Vice President, Global Regulatory Affairs and Pediatric Strategic Consulting; Premier Research Group, Philadelphia | Articles | Comments
With the reissuance of the Product Research and Equity Act, trial sponsors are encouraged to...
Assessing Cardiac Toxicity Using Stem Cell-derived Cardiomyocytes
April 11, 2013 4:02 pm | by Oksana Sirenko, Research Scientist; Carole Crittenden, Application Scientist; Evan F. Cromwell, Director of Assay Development; Molecular Devices LLC, Sunnyvale, Calif. | Articles | CommentsPredicting the side effects of drugs remains one of the industry’s greatest challenges, with a large percentage of new drugs failing in clinical studies due to cardiac toxicity. The overall success rate from Phase 1 studies is only 11%, with 30% of these failing for safety reasons.
JET Promotes 3Rs of Animal Studies
December 4, 2012 3:45 pm | by Robert A. Kaiser, Senior Research Scientist , Henry H. Holzgrefe, Senior Scientific Advisor, Charles River, Preclinical Services, Reno, Nevada | Articles | CommentsRecent technological advances have dramatically broadened the scope of safety pharmacology studies as originally envisioned in the International Conference on Harmonization (ICH) S7A and S7B guidances, where “the use of new technologies and methodologies in accordance with sound scientific principles” was encouraged.
Advancing Targeted Therapies with Molecular Imaging
August 24, 2012 2:53 pm | by D. Scott Edwards, PhD, Vice President and General Manager; Scifluor Life Sciences LLC, Cambridge, Mass. | Articles | CommentsA number of recently approved cancer drugs have utilized a companion biomarker test. Crizotinib was approved for lung cancer and vemurafinib for melanoma. Both were approved in less than half the time needed to approve oncology drugs in the 1990s.
Predicting Potential Cardiac Events
August 10, 2012 9:52 am | by Phil Atterson, MSc, Director of Pharmacology, Cardiovascular Sciences, and Specialty Toxicology Services; WIL Research, Ashland, Ohio | Articles | CommentsOne of the leading causes of drug attrition during development is cardiac toxicity, which has a serious impact on cost and can impact getting new drugs to patients. Detecting cardiovascular safety issues earlier in the drug development program would produce significant benefits for pharmaceutical companies and, ultimately, public health.
Detecting Potential Toxicity in Mitochondria
August 10, 2012 9:43 am | by Brad Larson, Principal Scientist; Peter Banks, Scientific Director; BioTek Instruments, Winooski, Vt. | Articles | CommentsMitochondria are responsible for more than 90% of a cell’s energy production via ATP (adenosine triphosphate) generation, in addition to playing a significant role in respiration and many signaling events within most eukaryotic cells. These intracellular powerhouses range in size and quantity within each cell depending on the organism and overall cell function.
A Better Focus on the Heart
June 13, 2012 10:34 am | by Peter Lee, Doctoral Student, Department of Physics; University of Oxford, Oxford, U.K.; Christopher E. Woods, MD, PhD, Cardiologist, Division of Cardiovascular Medicine; Stanford University, Stanford, Calif. | Articles | CommentsHigh levels of attrition during clinical trials are frequently due to the harmful effects compounds can have on the heart’s electrical activity and function.
Synthesizing Safety Data
June 12, 2012 5:03 pm | by Mark C. Wahle, PhD, Product Manager, Translational Science; Certara, St. Louis | Articles | CommentsQuestions about how to accurately and efficiently access and analyze drug safety data have plagued researchers and drug development scientists for years.
Predicting Pathway Effects
June 12, 2012 4:19 pm | by Pradeep Fernandes, Co-founder, President; Shireen Vali, Co-founder, Chief Scientific Officer; Cellworks Group Inc., Saratoga, Calif. | Articles | CommentsDrug development programs today have a 5% to 10% probability of success. Almost half of failures are due to drug safety issues found very late in the clinical development process.
Faster Pharmacokinetics
May 15, 2012 12:45 pm | by Mike May, Contributing Editor | Articles | CommentsPharmacokinetics plays a crucial role in a compound’s efficacy and safety and to characterize the pharmacokinetics of a compound, accurate measurements are needed.
Modernizing Toxicology for Drug Development
April 12, 2012 3:07 pm | by Michael P. Holsapple, PhD, Senior Research Leader; Brian M. Roche, PhD, Manager; Kim Henderson, PhD, Gordon Battelle Post-doctoral Fellow; James M. Sonnett, PhD, Vice President; Battelle Center for Fundamental and Applied Systems Toxicology,Columbus, Ohio | News | CommentsThe current approaches to toxicity testing and safety assessment rely on a complex array of traditional studies that evaluate observable outcomes in whole animals, such as clinical signs or pathological changes that are indicative of a disease state.
The Next Big Step for High-throughput ADME
April 12, 2012 9:34 am | by Neil Canavan, Contributing Editor | Articles | CommentsWhen considering the present use—and future potential—of high-throughput absorption, distribution, metabolism, and excretion assays, it is important to understand the context.
Transporting Drug Safety Forward
March 16, 2012 3:53 pm | by Catherine Shaffer, Contributing Editor | Articles | CommentsThe role of membrane transporters in drug-drug interactions is emerging as an increasingly important part of the overall picture of drug safety and drug metabolism.
Selling the Cell
February 21, 2012 10:52 am | by Neil Canavan, Contributing Editor | Articles | CommentsTesting to assess the metabolic fate of an investigational compound has moved away from animal models for two reasons: it’s increasingly seen as unethical and it’s increasingly obvious that it doesn’t work.
Therapy Dose Management During Clinical Development of Oncology Products
January 24, 2012 5:47 am | by Salvatore J. Salamone, PhD, Founder & Chief Scientific Officer; Edward L. Erickson, President & Chief Executive Officer; Saladax Biomedical Inc., Bethlehem, Pa.; Jack DeForrest, PhD, President; JDF PharmaConsulting LLC, Wycombe, Pa. | Product Releases | CommentsBody surface area (BSA) has long been the gold standard for determining the appropriate dose of chemotherapeutic agents. Numerous studies, however, have shown that this results in large patient variability due to variations in drug biodistribution, genetic variation, metabolism, and clearance.
Pharmacovigilance Analytics Software
October 28, 2011 12:23 pm | Product Releases | CommentsOracle Health Sciences’ Pharmacovigilance Operational Analytics provides a 360-degree view of a safety organization's case processing operations.
Early Safety Testing for Oncology Therapies
October 11, 2011 4:55 am | Product Releases | CommentsThere is considerable interest in drug safety among U.S. stakeholders, including the Food and Drug Administration, pharmaceutical companies, patient advocacy groups, prescribing physicians and their patients.
R & D for Drug R & D
October 7, 2011 12:00 pm | by Rita C. Peters, Editorial Director | Articles | CommentsA sister publication—R&D Magazine—will present the 49th Annual R&D 100 Awards this month. Among the top technologies and processes introduced in 2010 are many with direct applications in life sciences and drug research.
Simulations vs. Cells in ADME/Tox
October 6, 2011 10:34 am | Articles | CommentsTo be an effective drug, a compound must possess the proper characteristics when it comes to how it is absorbed, distributed, metabolized, and excreted—an area of pharmaceutical research known simply as ADME, and often combined with toxicology as ADME/Tox.
Companion Prospecting
September 12, 2011 7:24 am | by Ted Agres, Contributing Editor | Articles | CommentsCompanion diagnostics holds great promise for advancing the field of personalized medicine by allowing drug developers to identify subpopulations of patients likely to respond favorably or to experience unfavorable side effects from a drug or therapy.
Determining the First Dose
September 9, 2011 11:38 am | by Rob Harris, PhD, Director, Early Development; Molecular Profiles, Nottingham, U.K. | Articles | CommentsThe objective of a Phase 1, first-time-in-man clinical trial is to provide information on drug pharmacokinetics and pharmacodynamics in humans and to determine the appropriate dose to be taken into further clinical studies.
Biobetter Collaboration
September 9, 2011 11:09 am | by Mike May, PhD, Contributing Editor | Articles | CommentsBiobetter drugs offer unique opportunities and challenges. These drugs aim at similar targets and indications as existing biologic products, but provide some improvement other than price, such as efficacy, safety, or dosing regimens.
The Human Element in Toxicity Testing
August 1, 2011 10:27 am | by Vanessa Ott, Hepatocytes Product Manager; Blake Anson, Cardiomyocytes Product Manager; Cellular Dynamics International, Madison, Wisc. | Articles | CommentsCurrent in vitro cell models—such as animal cells, tumor cell lines, and cadaveric tissue—do not truly reflect human biology and have significant limitations in reproducibility and/or availability.
The Insoluble Solved
June 3, 2011 10:47 am | by Stephen B. Ruddy, PhD, Senior Director, NanoCrystal Technology, Product Development; Fidelma Callanan, MBA, Senior Director of Marketing and Communications; Elan Drug Technologies, Athlone, Ireland | Articles | CommentsDrug formulation scientists are devising reliable and robust technology solutions to overcome the solubility challenges of today’s complex drug designs and address a broader spectrum of drug-like properties that are likely to impact drug absorption, disposition, and toxicity.
FDA Investigates Drospirenone-Containing Birth Control Pills
June 1, 2011 11:21 am | News | CommentsThe U.S. Food and Drug Administration (FDA) issued a safety announcement informing the public that the agency is evaluating birth control pills that contain drospirenone. The review will evaluate the risk of blood clots in women who use these products.
Abbott Issues Statement on NIH Niacin Trial
May 27, 2011 4:59 am | News | CommentsAbbott issued a statement in response to decision by the National Institutes of Health to halt a trial studying the effects of niacin as potential heart protection.
