NorthEast BioLab aims to take your project through each phase of the drug development process, focusing on best practices and timelines in order to advance your drug program closer to FDA approval. In a recent blog post we attempted to put together a quick, easy-to-follow version of the step by step FDA drug development process for new drug approval. The road to new drug approval is long, with potential setbacks along the way. As a biotech or pharma company, you must consult with experts throughout the process to ensure that your drug program is heading in the right direction. NorthEast BioLab specializes in preclinical drug discovery services and has been working with clients for nearly 20 years as an FDA drug development CRO.
The pharmaceutical and biomedical industry are in the business of bringing new products to market. It’s no small task – developing a new drug or biologic can take anywhere from 8-12 years and requires a complex process that includes pre-clinical research, clinical trials and data analysis.The Phase 1 trial is the first step in the drug pipeline, and bioavailability dynamics are analyzed by measuring serum levels at various times, with an emphasis on determining overall safety. The dose, dosing frequency and route of administration are also determined in this phase.
The FDA phases of drug development is a massive undertaking, and selecting responsive partners who prioritize in sync with you for your new drug approval and focus on high quality and fast turnaround goes a long way in avoiding missteps and moving your drug program closer to approval. Today, biotech and pharma drug development processes succeed by shrinking the drug development timeline and outsourcing their needs to a drug discovery CRO like NorthEast BioLab.
Brain natriuretic peptide (BNP) or B-type natriuretic peptide is a hormone secreted by the human heart. Cardiomyocytes or cardiac muscles in the left ventricle secrete BNP. The left ventricle pumps oxygenated blood to different parts of the body and therefore controls blood pressure and volume.Brain natriuretic peptide (BNP) is a key hormone secreted by the human heart. Cardiomyocytes or cardiac muscles in the left ventricle secrete BNP. The left ventricle pumps oxygenated blood to different parts of the body and therefore controls blood pressure and volume.
The type B-type natriuretic peptide test detects a hormone produced by the heart in response to increased blood volume and body fluid retention. Heart failure causes an increase in the production of B-type natriuretic peptide (BNP), also known as brain natriuretic peptide and ventricular natriuretic factor.The pBNP test is a blood test used to determine if there are high levels of the hormone Brain Natriuretic Peptide (BNP). BNP is produced in the heart and released into the bloodstream when there is a change in fluid volume or pressure. It helps increase blood flow through the heart and reduce fluid accumulation in arteries and veins.
The b type natriuretic peptide test is a blood test used to help diagnose heart problems. Cardiomyocytes or cardiac muscles in the left ventricle secrete BNP. The left ventricle pumps oxygenated blood to different parts of the body and therefore controls blood pressure and volume. BNP is a moiety of a precursor protein, pro-BNP. The heart continuously produces pro-BNP. An enzyme Corin splits pro-BNP and releases two moieties, a 32-amino acid polypeptide active hormone BNP and a non-active 76-amino acid N-terminal prohormone NT-proBNP (also abbreviated as BNPT). In response to increased ventricular blood volume, the heart releases larger quantities of BNP and NT-proBNP. An increase in BNP and NT-proBNP facilitates fluid retention and volume expansion in the veins and arteries and causes the heart to stretch and pump more blood.”