Bioequivalence is the absence of a significant difference in the rate and extent of absorption of the active ingredient that reaches systemic circulation (bioavailability). If products have equivalent bioavailability, it is considered they will have the same clinical effects. BA/BE Studies will be performed by well-defined systems, procedures and with regulatory compliances.

Expertise in Various Type of Studies

• Parallel, Crossover, Partial, Replicate and Full Replicate.

• Long Housing Duration & Long Washout study

• Special Population Study: Post-Menopausal Women, Geriatric

• Multiple Dose Studies

• Steady-state Studies

• PD Studies

Various Routes of Administration (dosage forms)

• Oral formulations [Tablets (Immediate release & modified release, e.g., ER, DR, SR), capsules, soft gels, sprinkles, etc.]

  • Tablets (IR, ER, SR, MR, DR)

  • Capsules (Soft Gelatine, ER, MR, DR)

  • Suspension,

  • Granules

  • Sublingual

• Transdermal (Patch, Topical Cream, Topical Gel, Lotion)

• Vaginal (Tablet, Gel, Cream)

• Inhalation & Nasal

• Rectal products (Suppository & foam)

• Injection (IM, IV, Subcutaneous)

Bioavailability & Bioequivalence Studies

• Facility having clinical operation area more than 15000 sq.ft.

• Total 76 bed capacity divided in 03 clinical identical ward with emergency calling system facilitating simultaneous conduction of multiple studies.

• Separate housing ward for Female volunteers.

• Well-equipped Intensive Care Unit (ICU)-02 Beds.

• Dedicated Medical examination and ECG room

• Dedicated registration screening and subject waiting area

• Pharmacy Equipped with controlled access and environment for IMP storage in Ambient Temperature and 2-8℃

• Dedicated dosing area and sample processing area

• Subject recreation and dining area

• Volunteer Database: Approx. 3000 health Male and Female which include PMW

Clinical

Bioanalytical laboratory is equipped with state-of-the art Liquid Chromatography and Mass Spectrometry (LC-MS/MS) instruments. Our highly qualified team of scientists with in-depth knowledge in instrumentation and application of LC-MS/MS technology enables timely method development. We validate our analytical methods as per global regulatory requirements and we follow applicable GLP guidelines.

Sycon have state-of-the-art bio-analytical laboratory with fully GLP-compliant spread over 6000 sq ft and managed by highly skilled and experienced scientific professionals and support personnel.

• LC-MS/MS Lab (API-4500 with Analyst Software)

• Well-equipped Sample Processing lab

• Sample storage in controlled and limited access Cold storage area and Deep freezer with range of -20°C to -80°C.

• Online temperature monitoring and alarm system for Deep Freezers and Refrigerators.

• UPS backup for Critical Operations and Instruments and Generator power backup for entire facility

• Separate sample processing lab for photosensitive and environment sensitive molecules

• Access controlled entry and exit facility.

• Dedicated analytical and micro balance room

Bio Analytical