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BA/BE Studies

BA/BE studies are one of our Key services, we offer end-to-end solutions in this arena. Our cross-functional team has extensive experience in executing and managing Bioequivalence studies covering various therapeutic areas and complex studies.

Clinical Services

  • BA/BE studies on Healthy subjects
  • Patient based BA/BE studies
  • Food effect, Age Effect, Gender effect studies
  • Studies in both male and female subjects (Pre and Post postmenopausal women)
  • PK/PD end point studies
  • Single ascending dose (SAD) and Multiple ascending dose (MAD) studies
  • 505(b)2 studies
  • Short and long duration studies
  • Execution of studies on various range of formulations (Oral dosage forms, injectable, Suspensions and liquids)

Bioanalytical Services

  • State-of-the-art independent facility
  • Equipped with automated samplers to expedite the sample analysis process
  • Analytical scientists having experience in developing highly sensitive methods in a quick turn around time
  • Capability in analysing preclinical samples
  • Promptitude in MD/MV of off-patent molecules/First-to-file molecules
  • Capability of analysing 20,000 samples/Month
  • Our biomedical freezers (-250C and -750C) have the capacity to accommodate/store 150K biological samples

Pharmacokinetic & Bio-Statistics

  • Experienced Bio-statisticians working on various statistical tools (SAS, WinNonlin)
  • Study Design (protocol review, sample size calculation)
  • Statistical Analysis
  • PK/PD Studies and Bioequivalence Studies
  • Population BA/BE studies
  • Sample size calculation
  • Statistical Support in Regulatory Submission (FDA, Health Canada, EMA)
  • Developing CSR in a quick turn around time as per the regulatory specifications
  • CDISC (SDTM) datasets deliverables for submissions to regulatory markets such as USFDA

Glucose Clamping

Glucose clamp technique is a method for quantifying insulin secretion and resistance. It is used to measure either how well an individual metabolizes glucose or how sensitive an individual is to insulin. Our team has hands on experience in designing and executing the glucose clamping studies.

We offer the following services

  1. Protocol Design and Consultation
  2. Execution of Clamp techniques
  3. Clamp Data Analysis

Our Team Strengths