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BIOAVAILABILITY & BIOEQUIVALENCE STUDIES 

Chemxtree Standards’ team brings in considerable experience in conducting Bioavailability & Bioequivalence studies on healthy as well as patient population with various dosage forms including injectables like IM/IV/SC, Oral dosage forms like Solid Formulations (Modified Release Preparations), Liquid Formulations, Topical Preparations & Inhalations. 

The BA/BE studies conducted at Chemxtree are under a fully GCP-compliant facility.  The team consists of medical professionals supported by a team of clinical investigators, pathologists, physicians, clinical research associates, pharmacists, paramedics, and laboratory technicians, as well as well-equipped ICU facilities, state-of-art equipment, regulatory compliance software, and secured networks. We have a strong SOP-driven culture & ensure compliance with all statutory & mandatory requirements. We also support the regulatory queries at each step arising post submissions.  

Experience in handling various Dosage forms: 

  • Oral Dosage Forms [Tablet/Capsule (IR, DR, MR, SR, CR, ODT)] 
  • Inhalation/Pulmonary [MDI, DPI, Nasal Spray] 
  • Injectable Formulations [IM, SC, IV] 
  • Transdermal Patch Studies 
  • Topical Transdermal Gel & Cream 
  • Vaginal, Suppository 
  • Sublingual 
  • Cosmetics 
  • Suspensions/Liquids 

Experts in Different Types of Studies Design: 

  • Parallel Design
  • Two-Way Cross Over 
  • Three-Way Cross-Over/Partially Replicate Studies  
  • Four-Way Cross-Over/Fully Replicate Studies  
  • Fasting/Fed/Sprinkle Applesauce 
  • Complex generics 
  • Long Duration-Continous Monitoring Trials 
  • Special Population Trials 
  • Post-Menopausal Study 

Salient Features of Clinical Facility: 

  • The facility has separate access-controlled wards for Males & Females Volunteers  
  • More than 20,000 diversified volunteers’ database of Males, Females, Post-Menopausal Females & Geriatric 
  • Advanced software for Volunteer management 
  • Central Monitoring with CCTV 
  • Sample collection room having multiple stations matrix collections with separate matrix processing room 
  • pharmacy with biometric access 
  • Dining area is supervised by a qualified dietician 
  • In-House ECG facility 
  • ICF, Documentation & Biometry with software to ensure identity and avoid cross-participation 
  • Activity wise separate rooms for screening, counseling with audio-video recording  

Our aim is to offer enhanced CRO solutions on time while maintaining the highest levels of quality, cost-effectiveness, data integrity, and operational excellence