A full spectrum of Safety & Toxicology services from IND enabling to NDA submission. Operating at sites in the US, Canada and China, Frontage provides all the resources you need to support your nonclinical safety research and development plans. Our team of highly-experienced Study Directors, technicians, and program managers will help guide you through the critical phases of toxicity testing, from pilot tolerability and dose range-finding studies to definitive GLP toxicology studies required for the support of human safety. The early phase screening and pilot tolerability/PK studies conducted in both rodent and nonrodent models form the foundation for the subsequent definitive (GLP) toxicology studies and are important elements in a successful, nonclinical safety evaluation program. These studies include maximum tolerated dose (MTD), repeat-dose range-finding, exploratory PK, and feasibility studies needed to justify the design and dose-level considerations for the pivotal studies to follow. Frontage GLP toxicology studies have supported hundreds of successful client regulatory submissions globally. All standard dosing regimens and species (including nonhuman primates) are supported and are conducted in compliance with international GLP and animal welfare regulations. Our GLP studies are conducted in a wide range of animal models as appropriate for either small molecule therapeutics or biologics, across a wide variety of therapeutic indications. These studies are often part of IND-enabling programs as well as later-phase development chronic, reproductive/developmental, and carcinogenicity studies needed to support large-scale human trials and marketing permits. Our fully-integrated IND-enabling programs include general toxicology plus genetic toxicology and safety pharmacology as appropriate, plus all affiliated analytical / bioanalytical support elements, enabling the collection of robust and comprehensive data packages for IND submission and support. From pilot screening to IND-enabling, and ultimately to studies needed for the NDA, we offer comprehensive expertise to help design, execute, and report the studies required to satisfy your planning and regulatory safety obligations.
Science continues to prove that the old adage “you are what you eat” is profoundly true. This is because you have trillions of microorganisms living in your gut, which are directly responsible for nearly every aspect of your health. These microbes make up what’s called your “gut microbiota.” They are especially influential in determining your likelihood of gaining excessive weight, becoming obese, and developing obesity-related diseases like diabetes, heart disease, and premature death. The gut microbiome (the expressed genes of your gut microbiota) plays a major role in your metabolism through energy production, storage, and expenditure. So, it’s no surprise that science has found a strong connection between gut microbiome imbalance and metabolic syndrome. Yikes! If you have the wrong mix of microbes, it could be making it tough for you to get your health on track! Did you know: Scientists can actually look at your gut microbiome composition and tell with 90% accuracy if you are obese or lean. That’s pretty impressive, isn’t it?
1. Unable to lose weight and keep it off? 2. Struggling to fight cravings? 3. Sick of starving yourself for weight loss? 4. Baffled as to why no diet seems to really work for you? Depending on the composition of your gut microbiome, your microbes can either boost your health or weigh you down (figuratively and literally). The good news is this: You have control over these little guys with every bite you eat. Diet has the power to change the landscape of your gut microbiome. So, if you’ve tried multiple diets and can’t seem to get the results you want, it’s time to look into your gut microbiome.Will You Lose Weight Naturally on an Individualized Diet? If you’ve been struggling to lose weight and keep it off – it could be your gut microbiome. While Viome doesn’t guarantee weight loss, it has been an exciting result many of our customers have reported. “Fiona’s update day 37!
We know weight loss can be tough. Find out if your weight struggles are due to a gut microbiome imbalance with Viome – and let’s tip the scales in your favor. Your gut microbes actually digest much of your food for you. When your gut microbiota help digest your food, they turn it into nutrients, neurotransmitters, vitamins, hormones, and more. Through these metabolites, the composition of your gut microbiome influences nearly every metabolic activity. It’s accurate to think of your gut microbiome as an organ that’s part immune system and part energy regulator. If your gut microbiome is imbalanced, certain bacteria end up working to protect themselves from the harsh environment and are not able to help you. In the worst case scenario, you can have microbiota adding to your health problems, making it harder for you to get healthy lifestyle support and lose weight. Viome’s metatranscriptomic technology has allowed us identify microbial pathways and functions, specifically those that influence weight loss or gain.