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Clinical research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relief of symptoms in a disease.
What is bioequivalence?
Pharmaceutical products are bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives, and they display comparable bioavailability, when studied under similar experimental conditions. Bioequivalence is considered proven, in case the bioavailability, in terms of peak (Cmax and Tmax) and total exposure (area under the curve (AUC)) after administration of the same molar dose under the same conditions, are similar to such a degree that the effects of the studied products can be expected to be essentially the same.
What are bioavailability studies?
Bioavailability is the degree to which, or the rate at which, a medication or other substance is absorbed or becomes available at the targeted place in the body. Bioavailability can be influenced by inactive ingredients in the drug such as additives that prevent the medication from dissolving in the stomach.
Regulatory scenario in India for BA/BE studies and Phase I studies
Drugs Controller General (India) is the authority to grant permissions for the conduct of BA/BE studies with new drugs in India and Phase I studies. It normally takes about 6 weeks to get the permissions for the conduct of the BA/BE studies and for Phase I studies it may take longer.
How can Lotus Labs help you with your drug discovery program?
Lotus Labs provides a range of services in clinical research that involves clinical study planning, designing, conduct of studies from Phase I to Phase III providing end to end services right from protocol writing, regulatory submissions to the statistical analysis and report writing.
Can Lotus Labs Provide Central Lab Services for a multi centric trial?
Yes, Lotus Labs provides central lab services for clinical trials to Pharmaceuticals/ Biotech sponsors and to other Clinical Research Organizations too.
Is the Central Lab at Lotus Labs accredited by any regulatory body?
Central Lab (Medical Diagnostic Services) of Lotus Labs is accredited by NABL (National Accreditation Board for Testing & Calibration Laboratories) and CAP (College of American Pathologists).
Can Lotus Labs write protocols for ANVISA submissions?
Lotus Labs is approved by ANVISA and provides end to end services from protocol designing to final report generation. Lotus Labs will not be handling Pharmaceutical equivalence for ANVISA studies which need to be handled by the sponsor.
Does Lotus Labs have experience of conducting studies for USFDA?
Lotus Labs has experience of completing more than 350 studies for USFDA and as per the information available more than 100 are approved by USFDA (June 2010). All Lotus Labs facilities have been inspected by FDA for specific studies.
Does Lotus Labs have Phase I experience?
Lotus Labs has experience with First in Human studies, Single Ascending Dose, Multiple Ascending dose study.
What is Lotus Labs Labs experience in different therapeutic area?
Has Lotus Labs done studies for Narcotic Drugs?
No. Lotus is in the process of tying up with channel partners for providing these services in the coming days
Is Lotus Labs audited by EMA?
Lotus Labs has done many studies for EU submissions and the studies have been submitted to and approved by many EU countries. Lotus Labs has been audited by EMA, AFSSAPS & AGES for specific studies. Please contact us to know more.
Does Lotus Labs have any experience in vaccine studies?
Lotus Labs has experience with many vaccine studies. Studies on vaccines for Influenza on pediatric age groups (hospital based), healthy volunteer studies on Rota Virus and Malaria. We will also be initiating shortly studies on Rabies and Tuberculosis.
Has Lotus Labs done studies for Biosimilars?
Lotus Labs has experience with Erythropoietin and GCSF.
Can Lotus Labs provide stand alone services?
Lotus Labs can provide Stand alone services for medical writing, Statistical Analysis, Clinical Conduct, Bioanalytical Conduct, Monitoring and Auditing.
What are the credentials of Lotus Labs Labs?
Lotus Labs has been audited and inspected by authorities like FDA, EMEA, AFSSAPS, AGES, WHO, ANVISA, MCC (South Africa & Zimbabwe) and MOH Turkey.
Lotus Labs has successfully completed more than 39 such audits and is even approved for submission of studies in Israel and Sudan. More than 100 studies have been approved only by USFDA as per the information available. Lotus Labs studies have been submitted to more than 45 countries.
Does Lotus Labs has experience in conducting studies for WHO?
Lotus Labs has conducted studies for WHO submissions in the areas of ARVs(anti retrovirals) and Tuberculosis. Many of these studies have been approved by WHO and are featured in the WHO website.