Bioavailability & Bioequivalence

Fast & Fed Bioequivalence Studies

Relative Bioavailability Studies

Food Effect Studies

Multiple Dose (Steady State) Studies

Our state-of-the-art infrastructure spread over 12,000 sq. ft. facilitates one stop centre for executing BA/BE studies:

• 42 beds spread over 2 clinical units for simultaneous conduction of multiple studies resulting in quick turnaround time
• Clinical facility accomplished with Sample Collection Room, Recreation Area, Volunteer Dining Area, Nursing Staff, & Physician Room with necessary Clinical Equipments
• Volunteers database of 7000+ including male- and female healthy volunteers as well as hypogonadal subjects
• Bioanalytical lab with 5 LC-MS/MS and HPLC instruments of Ab Sciex and waters for estimation of drugs and metabolites
• Assay bank of more than 120 methods, developed and validated as per the regulatory norms
• Sample storage facility with controlled temperature at - 80 °C and -40°C
• Access controlled pharmacy unit with continuous temperature & humidity monitoring

Our operational competence:

• Bioavailability (BA), Bioequivalence (BE), Pharmacokinetics (PK), Pharmacodynamic (PD), Dose Linearity, Multiple Dose and Steady State studies
• Studies with dosage forms including immediate release (IR), controlled release (CR) modified release (MR), extended release (ER), solid oral, oral thin films (OTF), oral dispersible tablets (ODT), sublingual, injections, gels and suspensions.
• Studies with variety of therapeutic areas including cardiovascular, infectious diseases, psychiatric, gynaecological, endocrine, neurological, anti-inflammatory, anti-infective, analgesic, gastrointestinal, respiratory, urological and dermatological
• Proximity to emergency facilities

Protocol Design

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      • Protocol preparation group having medical or pharmacy background and experience of conducting clinical studies. They design clinical study protocols in coordination with Project coordinator, biostatistician and panel of consultants if required.
      • Our clinical physicians and consultants work closely to offer scientific inputs for study.
      • The designed protocol will be reviewed by PI, Biostatistician, Bioanalytical Investigator & QA before it is shared with sponsor

Subject Recruitment & Screening

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      • Large volunteer database (More than 7000 - males and females)
      • We recruit from the pool of 7.224 million population of Pune city & adjoining areas.
      • This large pool allows Synapse to recruit volunteers for studies rapidly.
      • All subject screening activities are conducted in a separate screening area within the same facility.

Clinical Study and Project Management

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      • Study Director is appointed for each study by the management. Study director appoints Principal Investigator, Bioanalytical investigator and Biostatistician for each bioequivalence project.
      • Each project is managed by the appointed project coordinator who will be responsible for coordinating all study related activities from protocol design to report submission

Bioanalytical Services

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Synapse offers you extensive bio-analytical services in drug development by conducting analysis ranging from evaluation of drugs in samples to biostudies. We have put together a team with strong scientific knowledge combined with the latest automated equipment to meet the needs of our clients. Our ability to undertake studies for special population & unconventional molecules sets us apart from the competition. The bio-analytical department with entry/exit access controls has a carpet area of approximately 2000 Sq. ft.
      • Method Development and Validation
          Our method development team is committed to develop methods with lowest LOQ and very rapid turnaround time. Methods are validated on LC-MS/MS or HPLC in compliance with norms of US FDA and other applicable regulatory agencies. We can source Reference Standards, Metabolite, Deuteriated compounds as per method requirement
      • Bioanalysis
          We provide following bioanalytical support with team of qualified analysts:

• Analysis of drug and /or metabolite (s), pro-drugs in biological samples as per study requirements
• Adaptation and revalidation of sponsor’s assay methods
• Method for drug-drug interaction studies
• Chiral analysis
• Analysis of multiple analytes from combination drug products
• Analytical group works into three shifts allowing 24/7 operation of our analytical equipment and ensuring that client’s timelines are always met.
• Online systems capture information with networked temperature monitoring of all refrigerators, deep freezers and drug storage.
• Our goal is to provide the accurate analysis in the shortest possible time while maintaining full compliance with regulatory requirements.
• The lab offers highly selective and sensitive assays of drugs, metabolites in biological fluids.
• QC and QA procedures ensure that our lab produces top quality and credible data with no room for discrepancies.

Capabilities:

• Capacity to analyze approximately 25,000 + samples / month
• 110+ validated methods and continuously developing new methods as per requirements.
• Method transfer or cross validation between instruments & matrices
• Bioanalysis of drug and metabolites in a variety of biological matrices from preclinical and clinical trials
• Ability to develop and validate highly sensitive assays in low pg/mL range
• Ability to develop and validate methods well in advance based on patent expiry and business sense
• Qualified, trained & experienced team of bioanalytical professionals

Sample Storage:

• All study samples are stored in secure deep freezers (05 in number), controlled and continuously monitored and supported by a standby generator & UPS (Uninterrupted Power Supply) system
• Sample controlled temperature storage - -80 °C (03 in number) and -40°C (02 in number)