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.
With the reissuance of the Product Research and Equity Act, trial sponsors are encouraged to...
Predicting 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.
Recent 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.
A 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.
One 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.
Mitochondria 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.
High levels of attrition during clinical trials are frequently due to the harmful effects compounds can have on the heart’s electrical activity and function.
Questions about how to accurately and efficiently access and analyze drug safety data have plagued researchers and drug development scientists for years.
Drug 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.
Pharmacokinetics plays a crucial role in a compound’s efficacy and safety and to characterize the pharmacokinetics of a compound, accurate measurements are needed.
The 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.
When considering the present use—and future potential—of high-throughput absorption, distribution, metabolism, and excretion assays, it is important to understand the context.
The 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.
Testing 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.
Body 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.
Oracle Health Sciences’ Pharmacovigilance Operational Analytics provides a 360-degree view of a safety organization's case processing operations.
There 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.
A 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.
To 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 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.
The 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 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.
Current 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.
Drug 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.
The 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.