BA/BE Studies Services

Bio Studies is one of the key services that we offer at Lotus Labs. The various studies on bioavailability, bioequivalence and pharmacokinetics are conducted at our centers in strict compliance with international regulatory requirements, meticulously monitored by an independent quality assurance department. Our expertise in bio-analytical services has ensured the development of over 230 validated bio-analytical methods with the wherewithal to analyze over 25,000 samples per month. Lotus Labs has constituted a dedicated team to develop and validate new methods for ba/be studies. This team is competent to develop and validate a minimum of 5 methods every month.
At Lotus Labs, our Bio Studies portfolio includes various ba/be Studies, Phase I Studies (conducted in healthy volunteers) and PK / PD & Patient Studies (conducted in special populations).
 

Capabilities

Backed by rich experience in conducting studies in healthy human males, females and post menopausal females – Lotus Labs brings vast expertise to the conduct of these studies – to analyze diverse aspects such as absorption, distribution and elimination of various drugs using different types of formulations. Protocol development, submission to IEC`s and associated approvals are an integral part of the study process.

At Lotus Labs, our ba/be studies address various formulation types that include:

  • Solid Oral Formulations – Tablets, Capsules, Soft Gels, Sprinkles, IR, ER, DR, SR & PR
  • Liquid Formulations – Suspensions & Syrups
  • Parenterals – Intra Muscular, Intra Venous & Subcutaneous
  • Orally Dispersible Formulations
  • Sprays – Nasal & Oral
  • Inhalers
  • Dermal Patches
  • Blanching Studies

Lotus Labs has considerable experience in conducting ba/be studies with various dosage forms including injectables like IM/IV/SC, oral dosage forms like solid  formulations (Modified Release preparations), liquid formulations, topical preparations and inhalations. The ba/be studies conducted at Lotus are fully GCP compliant.

Infrastructure

Clinical facilities at Lotus Labs are spread across 4 locations aggregating a capacity of over 360 beds, with separate areas for subject screening and blood draws, pharmacy, state-of-the-art fully equipped ICU’s and tie-up with a multi-specialty hospital in the vicinity to handle emergencies.