SpinoS Life science and Research Private Limited is an independent Clinical Research Organisation located in Coimbatore, Tamilnadu started its operation in July 2016.
In SpinoS ,our expert team handled BE studies for most of the dosage forms like tablets, orally disintegrating tablets, capsules, suspensions, patches, vaginal tablets, syrups etc.,
Some of the case studies are as follows..
Successfully completed Bioequivalence study and food effect study for Teriparatide. Teriparatide is a form of parathyroid hormone using ELISA method 0.1 to 1000 pg/mL.
Completed the WHO submission study for Albendazole and EU submission study for Lapatinib 250 mg (Highly Varaiable drug)
SpinoS team has vast experience in conducting BE studies for Narrow Therapeutic Index drugs.
One such example is Dabigatran Etexilate Mesylate capsules. It is a highly variable drug and has Two analytes Free (non conjugated) Dabigatran and Total (non conjugated plus Conjugated) Dabigatran
Study is considered valid only when there is a proof for complete alkaline cleavage of the Dabigatran glucuronide.
Due to its steep exposure relationship, we cannot use fully replicated design for BE criteria considering the narrow therapeutic Index. The within-subject variability of test and reference products should be compared and the upper limit of the 90% confidence interval for the test-to-reference ratio of the within-subject variability should be ≤ 2.5.
Hence only average Bioequivalence approach need to be used. A special SAS program is developed and validated to meet the regulatory requirement.
SpinoS team has expertise in conducting “First to file” studies for USFDA submission with a quick turn around time. Minimum turn around time we took to complete a “First to File” study was seven days. Within seven days of Investigational Product receipt we have submitted the report to the USFDA in seven days.
SpinoS team has expertise in designing protocol and conducting studies for 505 B2 application apart from ANDA submissions. We support our clients right from the design till submission to FDA. One such molecule is Abiraterone capsules, where in we designed the protocol, Obtain No objection from Indian Government and successfully completed the studies on time to sponsor.
In SpinoS , we have conducted several studies on long terminal Elimination half life. Some examples are Aripiprazole, Bicalutamide, Vortioxetine, Dutasteride etc.,
Especially in Aripiprazole, specific inclusion criterialike healthy male with age group of more than 45 years has to be included. Several Adverse events were expected in administering Aripiprazole, Hence subject were recommended for continuous ECG monitoring during the stay.
Due to its long half life, some studies were also conducted in parallel design with truncated AUC upto 72 hrs.
SpinoS conducts BE studies on highly variable drugs like Paroxetine, Budesonide using fully replicate / Partial replicate study designs.
SpinoS conducts BE studies on special population like post menopausal female with the age group of 45 – 65 years for molecules like Estradiol
SpinoS conducts BE studies on menstruating female with the age group of 18 – 45 years. Some of the examples are MethylErgonovine Maleate tablets 0.2 mg, Ulipristal Acetate Tablets 10 mg etc.,
SpinoS conducted BE studies on long housing of upto 30 days .
Molecules like Ursodiol, Omega 3 Fatty acids , Lanthanum carbonate were one among the same.
SpinoS has vast experience in conducting BE studies with various matrix like Urine for lanthanum and Faeces for Orlistat.