Bioequivalence Study

Bioequivalence Studies

Discription : Bioequivalence and Bioavailability Studies Bioavailability (BA) refers to the rate and extent to which the active ingredient or active moiety of a drug is absorbed from a drug product and becomes available at the site of action. It is a critical pharmacokinetic measure that determines the efficiency of a drug's delivery into the bloodstream when administered through various routes, most commonly oral. Bioequivalence (BE) studies, on the other hand, compare the bioavailability of the same drug from different formulations (usually a generic product vs. a brand-name product). Two drug products are considered bioequivalent if they show no significant difference in the rate and extent of absorption when administered at the same molar dose under similar conditions.

Pharmadesk is providing consulting & complete project management services to generic pharmaceutical companies for Bioequivalence and related activities. We have been supporting Generic Pharmaceutical companies in Product feasibility assessment, CRO selection, Medical writing, Project management for BE study, BE study monitoring, Failed BE study analysis, IVIVC and Regulatory support regarding BE studies. Our strength is our technically sound team who have been constantly delivering the projects within time. We provide a deep insight to your generic product development and ensure a risk mitigation strategy is in place for bioequivalence program to save millions of dollars for your organisation.

Azidus has a dedicated volunteer mobilization team which does motivation and mobilization of the volunteers. More than 4000 volunteers including adult healthy males & females, post menopausal females and geriatric volunteers are registered in the data bank. Biometric software is used for volunteer identification and retention, in Azidus. The finger prints of the volunteers will be captured into the software during registration process. Azidus can undertake the following studies. Single & multiple dose studiesFasting & Fed studiesFood Effect studiesPK PD studiesCross over and parallel studies Replicate studiesProof of concept studiesSpecial population studies (postmenopausal & adult female studies and geriatric studies) BA/BE studies are conducted in extremely controlled environment and all the clinical, bioanalytical and data management activities are strictly driven through SOPs. Facilities to conduct 15 Pilot & 5 Pivotal BA/BE studies in a month. In other words, we can handle about 500 volunteers per month. The studies are conducted as per the ethical committee approved protocol, SOPs, current GCP, GLP standards and applicable regulatory requirements. The sponsors will be contacted and communicated during the each stage of the study and updated about the proceedings of the study

SpinoS BA/BE division has an experienced scientists comprised of, Clinical pharmacologists and life science personnel. SpinoS team has an experience of conducting more than 300 studies together which results in delivering quality job. Successfully faced two USFDA audit with NIL 483. We have conducted over 300 studies with a back up of 30,000 healthy subjects including Post menopausal females. We have expertise in conducting

Engaged in the providing services such as Bioavailability (BA) and Bioequivalence (BE) studies.

At AXIS, we share your passion for the advancement of medicine and understand the need for innovative solutions to accelerate your product s time to market. Exceptional team chemistry and dedication to service are the hallmarks of our workforce. We, the premier service provider of Clinical Pharmacology Services, specialize in providing safe and ethical research solutions for Bioequivalence - Bioavailability studies. Our domineering experience in conducting a full range of bioavailability / bioequivalence clinical studies has given us a complete understanding of the generic development process, which gives confidence to our sponsors that the outsourced project will be completed professionally and with most expeditious economic way possible. Our large infrastructure ensures the quick accommodation of your project for male / female or special populations. The pharmacokinetic, bioavailability and bioequivalence studies are conducted at our facilities in strict compliance with national and international regulatory guidelines that are monitored by independent quality assurance team. With fewer levels of management, our staff members are able to respond quickly to a client s request and initiate action without having to consult a committee. Our team members take ownership of the project, providing clients with a more personalized, strategic approach to clinical management in the context of the phase, location and objectives of the study. At AXIS Clinicals, we offer specialized services in the following types of studies: Fasting and Fed conditionSingle and multiple dose in healthy subjectsDrug-drug interaction, drug-food interactionVarious Routes of AdministrationSpecial | Patient Population (PK | PD) studies

There are provisions to accumulate 24 healthy human volunteers at a time in the cozy air-conditioned CPU(Clinical Pharmacology Unit). Prior to undertaking the B.E.studies all the protocols approved by Institutional Etheical Committee(IEC) of Jadavpur University constituted as per guidelines of ICMR. The B.E. study is carried out under the guidance of clinical pharmacologist, medical officer, nurse,and medical labratory technicians where the analysis of blood plasma concentration of drug by HPLC is being carried out by experinced Scientists at the sophisticated analytical labratory.

Oncology studies services support cancer research, diagnosis, and treatment. These services may include clinical trials, biomarker analysis, tumor profiling, and preclinical testing of anti-cancer therapies. They help advance our understanding of cancer and develop more effective treatments.

SERVICES WE OFFER Acute toxicity studies Sub-acute toxicity studies Chronic toxicity studies Irritation studies chemicals Allergic sensitization Reproductive toxicity studies Carcinogenicity studies Mutagenicity studies Biocompatibility studies Eco-toxicity studies Supplementary toxicity studies SECTORS WE SERVE Drugs pharmaceuticals Cosmetic personal care products Medical Devices Analysis, Impurity profile Quality evaluation Food Farm products Microbiological Studies Cosmetic personal care products Toxicological / Biosafety Pesticide, Agrochemical Industrial Stability studies, Shelf life studies Chemicals Contraceptives: Oral Implants etc Method Development Genetically modified products Residue analysis for pesticides, heavy metals antibiotics etc. Herbal Ayurvedic formulations. Residue analysis for mycotoxin, Aflatoxin, Ochratoxins,Fusarium etc.

EnEm s expertise in Bioequivalence and bioanalysis services over the year has been extended to offer wide range of clinical research services. Our success is driver by our commitment to support customers with thorough understanding of the critical importance of the time, project management and GCP & GLP compliance.Our strength is its team of ethical, experienced, knowledgeable, customer focussed professional.Clinical ServicesFacilitySpacious clinical ward with an area of about 10,000 sq. ft.One fully equipped 2 beds ICUState-of-the-art two identical clinical wards of 36 beds each comprise total beds to 72 Proximity to a hospital that will facilitate quicker and better handling of emergencies Pharmacy with controlled access Counseling room with audio-video recording facility Emergency calling point at bed and in wash room A recreational facility for subjects during the study Dedicated nurse/lab technician for samples withdrawal and care Volunteers data bank for recruitment of healthy human volunteers-800C deep freezers for plasma sample storage which are continuously monitored through data logging system ExpertiseCan Conduct the studies in different Therapeutic area like, lipid-lowering agents, anti-diabetics, antidepressants, Antibiotics, NSAID's, antiepileptic, muscle relaxant, cardiac drugs, Herbal and Nutraceuticals etc.Experienced in conduction of Onco Products on healthy volunteersExperienced in conduction of Cardiac Monitor study on healthy volunteers Studies perform on different formulations like, Tablet, Capsules, Syrups, Suspension, IV, Sprays etc. Can handle male and female volunteers study simultaneously Lead time to finalization of documents is very less Submission of reports in eCTD formats Bioanalytical ServicesBioanalytical Lab offer comprehensive bioanalytical services for small molecule development including:Pharmacokinetic (PK) AnalysisBioavailability Studies Bioequivalence Studies Drug Interaction StudiesOur bioanalytical facility is well equipped with highly sophisticated instruments and multiple state-of-the-art resources, ensuring a straightforward and compliant submission for any country. The team comprises of well-trained and experienced Scientists. Our comprehensive analytical SOPs ensure compliance with good laboratory practice (GLP) and current regulatory guidance documents.Our expertise, combined with our state-of-the-art instrumentation, allows us to achieve:Extremely low LLOQWide linearity range Analysis of multiple drug/metabolites in single method Analysis from various biological matrices Quick method development We can perform assays for over 150,000 samples per year, many for multiple analytes and comprising parent drug and several metabolites in one single assay. Sample analysis is performed for projects carried out in our own clinics as well as for external projects.ArchivalInhouse archival facility with about 1,500 sq. ft. Our StrengthState of art Infrastructure with the updated instruments in Compliance with GxP norms to complete the project most efficiently and effectively with uncompromised quality.Dedicated R&D team with vivid experience in formulation development, analytical research, bioequivalence studies which understands your goals / Innovative / cost - effectiveness.

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Bioequivalence - Bioavailability Studies

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