Bioavailability of a drug, refers to the rate and extent to which the active ingredient is absorbed from a pharmaceutical formulation and becomes available at the site of action.
What is bioavailability? As bioavailability is one of the most essential elements in developing a generic drug and conducting comparative studies, it is essential to truly understand the importance of both bioavailability and bioequivalence studies in development of generic drugs.
Generic drugs contribute to modern healthcare by making safe, effective and low- cost alternatives to currently available medicines. They are also more affordable for insurers and patients than their brand name counterparts.Bioavailability is one of the most important factors that influences the pharmacokinetic parameters of a drug molecule. It represents an indicator of how well the administered dose fraction reaches the systemic circulation after being absorbed via a certain dosing route. A drug is considered to be 100% bioavailable when it is administered intravenously, as absorption takes place directly into the bloodstream or central compartment. However, for other dosage forms, such as oral administration, bioavailability is limited due to various hindrances in gut as well as liver.
Bioavailability is a pharmacokinetic concept based on the effectiveness of a given dosage form for delivering a drug to a target site in the body via a specific route of administration. Bioavailability can be affected by numerous factors such as drug interactions, chemical stability, preservative efficacy, and environmental stress. Various aspects like physical, chemical, biological and immunological properties of the drug also render it susceptible to drug-drug interactions.
At NorthEast BioLab, we specialize in validation, biochemical, biophysical and pharmacological characterization of your therapeutic antibody in vitro. We also provide complete IND-enabling package for your antibody to help you meet the deadlines.New drug development is a mammoth task that takes years, costing upwards of $1 billion. Our goal is to bring quality drugs to the market faster. We negotiate with the USFDA & govt agencies to get you approvals as quickly as possible, cutting down the time and costs for successful launch of your drug.
A new drug is one that has not been previously approved by FDA. Many drugs must go through several stages of clinical trials, or studies in people, to determine how well they work and to identify possible side effects. It requires preclinical testing, investigational new drug (IND) applications, and completed clinical testing before marketing approval from the FDA. The overarching goal is to bring more efficient and safer treatments to the patients as quickly as possible after a thorough medical evaluation.
Molecular biology are increasingly used to develop novel and safe drugs. They are in a position to take advantages of new technologies which have revolutionized the research and development of new drugs. Biotech drug development has also changed the face of drug development in recent years. Companies are using diagnostic tools to design personalized therapeutics based on your individual DNA fingerprint. The central resource for this transformation is the pharmaceutical industry itself, which is developing more targeted drugs for more patients with less toxic side effects, and investing significant sums in R&D to develop next generation biologic products that will impact our health for many years to come.
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