A generic drug is the formulation that has the same performance as an innovator product, including same dosage, effectiveness, dosage form, strength, quality and other properties. The greatest advantage for a generic drug is far more economical compared to the Innovative ones. As an alternative form for the branded medicines, generic drugs have an increasing market share in recent years since they are safe and effective and of the same high quality. Taking the United States for example, the generic copy has accounted for 69% of all prescriptions dispensed and the dollars spent on prescriptions only accounted for 16% of all budget.
As regulated by the FDA, the quality of the generic drugs should meet the standards for brand name drugs. To ensure your generic products can meet the strictest demand for scrutiny, the ingredients including active agents and the inactive components, clean class and facilities at BOC Sciences are all required to meet the federal guidelines for Good Manufacturing Practices.
Given the fact that almost all of the innovators are generally protected by a suite of patents and the exclusivities, approving of a generic drug to market is hence significantly challenged. Prescription technology redevelopment may represent an efficient and popular method to sidestep the drug patents by differing your generic medicines from the branded drugs.
The bioavailability (BA) and bioequivalence (BE) study play a pivotal role in the evaluation of whether the generic drug and the brand ones have the same efficacy and/or toxicity by determining the pharmacokinetics (PK) parameters. Through several evaluation methodologies, our Worldwide Clinical Trials experts can provide BA/BE services according to the local regulations. To ensure your project is promoted in a more efficient and timely way, we have established a high quality BE workflow as below:
With knowing the strong aspiration to produce high quality pharmaceutical products, the generic medicine experts at BOC Sciences have enough professional knowledge to help you determine the most optimal formulation to ensure the generic ones are made to the same standard as branded medicines. Moreover, through identification of the most critical needs of patients across the globe and the potential profit margin, our strategist will assist you to select the most valuable program to maximize the benefits.