BA/BE Studies in Clinical Research
SpinoS BA/BE division has an experienced scientists comprised of, Clinical pharmacologists and life science personnel. SpinoS team has an experience of conducting more than 300 studies together which results in delivering quality job. Successfully faced two USFDA audit with NIL 483. We have conducted over 300 studies with a back up of 30,000 healthy subjects including Post menopausal females.
We have expertise in conducting
Our Process of BA/BE Studies
☆ BA/BE studies are conducted in SpinoS are in extremely controlled environment and all activities are strictly driven through SOPs.
☆ We are expertise in delivering the project on time with a turn around time of 45 days from the initiation till the final report.
☆ The studies conducted are approved by the Independent ethical committee, all the procedures in clinical and bioanalytical are SOPs driven, in accordance with current GCP, GLP standards and applicable regulatory requirements.
☆ Individual project managers will be allotted to each project and close coordination with sponsor to cater all their requirements.
☆ With a vision of most preferred research partner we believe in developing cordial relationship with our entire sponsors through exclusive and efficient project management to all their projects.
BA/BE Studies in Clinical Trials
Bioavailability (BA) Studies in Clinical Trials : Spinos excels in conducting Bioavailability (BA) studies, essential for evaluating how drugs are absorbed and distributed within the body. With a focus on precision and reliability, Spinos ensures:
Expert Assessment of Drug Absorption : Spinos employs rigorous methodologies to assess how drugs are absorbed and distributed, providing crucial insights into their efficacy.
Optimization of Dosage and Administration : Leveraging BA data, Spinos assists in determining optimal dosage, formulation, and administration routes for enhanced drug effectiveness.
Therapeutic Equivalence Evaluation : Spinos conducts BA studies to meet FDA guidelines, demonstrating the therapeutic equivalence of drug products through meticulous clinical trial settings.
In-depth Pharmacokinetic Analysis : Utilizing advanced pharmacokinetic parameters, Spinos measure absorption rates, extent of absorption, and elimination half-life, contributing to comprehensive drug development.
Safety
Spinos Places Utmost Importance On Safety Within The Clinical Trial Design, Ensuring:
☆ Effective Communication and Safety Oversight : Spinos ensures prompt result communication, emphasizing participant welfare, and collaborates with DSMB for continuous safety oversight.
☆ Adverse Event Reporting and Ongoing Monitoring : Spinos adheres to safety protocols, reports events promptly, and conducts continuous analyte monitoring for participant safety assurance.
BA/BE (Bioequivalence and Bioavailability) Studies on Healthy Subjects
In pharmacokinetics, "bioequivalence" refers to the expected in vivo biological equivalence of a generic version to its proprietary version of a drug or formulations of an innovator drug in various clinical trial phases.
Raptim has conducted more than 1100+ BE studies and has about 30,000 healthy volunteer data base. The types of studies we can conduct are:
Objectives
☆ Ensure the rights, safety, and welfare of human subjects participating in drug studies
☆ ensure the quality, integrity, and validity of clinical, analytical, and statistical data from BE studies
☆ ensure compliance with applicable FDA regulations and the identification of significant deviations.
Bioequivalence (BE) Studies in Clinical Trials
Spinos is at the forefront of Bioequivalence (BE) studies, a critical component in pharmaceutical development. The company excels in ensuring:
Thorough Pharmacokinetic and Pharmacodynamic Assessment : Spinos meticulously measures key parameters post-drug administration, providing a robust evaluation of drug equivalence.
Efficient Study Design : Following FDA regulations, Spinos implements randomized crossover designs with appropriate washout periods, guaranteeing reliable and accurate results.
Comprehensive Evaluation of Therapeutic Equivalency : Spinos conducts BE studies to assess absorption and elimination characteristics, a pivotal indicator of therapeutic equivalence between drugs.Incorporation of Innovative Approaches: Recognizing the evolving landscape, Spinos explores and adopts efficient approaches to Bioequivalence assessments, contributing to the approval of high-quality generic drug products worldwide.
Regulatory
☆ Spinos Aligns Seamlessly With Regulatory Requirements In Conducting Ba/Be Studies, Ensuring :
☆ ICH E3 Compliance : Spinos meticulously follows ICH E3 guidelines, crafting Clinical Study Reports with detailed methodology, statistical analysis, and safety evaluation.
☆ Regulatory Precision : Spinos adopts standardized formats, such as the Common Technical Document, ensuring consistency and facilitating regulatory submissions with log-transformed BE measures.
Spinos Life Science and Research Private Limited
SpinoS was established with an aim to build a full-fledge CRO offering end to end service with respect the phase studies, with system and process in compliance with global regulatory standards.
Bioavailability & Bioequivalence
The utter lack of a major difference in the rate and quantity of absorption of the active ingredient that reaches systemic circulation is referred to as bioequivalence (bioavailability). It is assumed that if two products have equivalent bioavailability, they will have the same clinical effects. Bioavailability Bioequivalence studies are conducted using well-defined procedures and include the following steps:
Our Therapeutic Experiences
Oral solid formulations
Formulations for Parenteral Administration
Transdermal Topical
products
Inhalation
Sprays for the Nose and Mouth
Products for the
Rectum
Vaginal Care Products
