Assessing BA BE Studies Methods

BA BE studies are required to ensure therapeutic equivalence between a pharmaceutically equivalent test drug and a generic drug or reference drug. BA/BE studies are finished Early and late clinical trial definitions, Formulations utilized as a part of clinical trial and steadiness studies. Submission of application for new drugs under schedule Y should be required to furnish the bioavailability and bioequivalence data, that is, mainly focus on the drug release from the pharmaceutical dosage form and subsequent absorption into the systemic circulation.

Bioavailability (BA) is defined as the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.

• Methods for assessing the bioavailability
• Pharmacokinetics methods
• This method reflects the therapeutic effectiveness of a drug. Thus these are indirect methods. Plasma-level time studies Urinary excretion studies
• Pharmacodynamics methods
• This method involves direct measurement of drug effect on a physiologic process as a function of time. Acute pharmacologic response therapeutic response

Veeda is one of the Best BA BE CRO in India. It has submitted on average of 10% of all USFDA submissions over the last 3 years. It has the expertise needed in a Contract Research Organization partner to ensure the quality conduct of the study.

Veeda is an Independent Contract Research Organization in India providing a broad range of skills, offering you a complete spectrum of services covering all the needed elements to make your clinical trials research work successful.

Biologics and Biosimilars team includes Clinical Research professionals, Physicians, Medical Writers, Safety Experts, Bioanalytics with extensive experience in supporting the development of Biosimilars for Indian and Global Registration. The team works with a focus on developing Veeda CR as a leading service provider in the field of Biologics - both novel and Biosimilars. We understand that this class of drugs provides exceptional challenges and requires in-depth knowledge and 'out of the box' thinking, which our group is capable of.

We aim to provide services at three levels. Firstly, as a CRO we will undertake to develop your Biological drug in the clinical environment which is mandated for its acceptance in the major markets of the world. At a higher level, we would aim to advise your in-house project team on the most strategic ways forward with the molecule which you have developed. This means an intense focus on the ultimate markets for which you are aiming and the customizing of the clinical trials program to meet those markets. In a perfect world, it would be possible to have one series of trials for all markets but regulatory differences between countries means, for instance, that the reference drugs may be different.

Bioequivalence is defined as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.

There are four types of equivalences:

1. Chemical equivalence
2. Pharmaceutics equivalence
3. Therapeutic equivalence
4. Bioequivalence

Veeda Clinical Research is an Independent CRO which offers a fully integrated package to its clients for studies ranging from PK in healthy volunteer to Patient trials for generics, Nce and Biopharmaceutics.