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Bioavailability & Bioequivalence

Bioavailability & Bioequivalence Studies

ICBio has a world-class infrastructure to facilitate quality research and is a GCP compliant facility manned by an experienced team of medical professionals and supported by a team of clinical investigators, pathologist, physicians, Clinical research associates, pharmacists, paramedics, and laboratory technicians, as well as a well-equipped ICU facilities, state-of-the-art equipment, regulatory compliance software and secured networks.

A team of 50+ dedicated employees with over 90+ years of experience in clinical research and expertise in executing all types of dosage forms.

The ICBio team has excellent scientific expertise and the ability to handle difficult studies to support various regulatory agencies such as DCGI, ISP Chile, EMA, MHRA and TGA and others.

Bioavailability_and_bioequivalence_studies

ICBio has a world-class infrastructure to facilitate quality research and is a GCP compliant facility manned by an experienced team of medical professionals and supported by a team of clinical investigators, pathologist, physicians, Clinical research associates, pharmacists, paramedics, and laboratory technicians, as well as a well-equipped ICU facilities, state-of-the-art equipment, regulatory compliance software and secured networks.

A team of 50+ dedicated employees with over 90+ years of experience in clinical research and expertise in executing all types of dosage forms.

The ICBio team has excellent scientific expertise and the ability to handle difficult studies to support various regulatory agencies such as DCGI, ISP Chile, EMA, MHRA and TGA and others.

BA and BE Studies in Healthy Volunteers

Experience in handling various Dosage forms:

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Expert in different types of Studies designs

BA/BE Studies in Patients

ICBio provides best-in-class services to conduct patient-based bioavailability/bioequivalence studies and complicated generic drugs for our drug development clients, combining knowledge and experience in bioequivalence studies. To undertake patient PK investigations and clinical endpoint studies, we have liaisons with major hospitals and investigators. We have extensive expertise performing research in all major therapeutic areas, including Oncology, Psychiatry, Ophthalmology, Dermatology, and others.

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Pharmacokinetics (PK) Studies

We provide project planning to build quality into PK investigations from the start with risk-mitigating strategies efficient and effective schedule and budget planning, and performance optimisation. The team has worked with the risk management plan, the safety management plan, the QA audit plan, the IMP plan, the data management plan, the edit check plan, the monitoring plan, the project management plan, and the PK sample management plan. The team has been extensively trained to carry out all of these strategies. Most importantly, project managers always have a risk mitigation plan in place for unanticipated scenarios that may arise during a PK research.

Clinical End Point Studies

Our clinical endpoint studies monitoring services include study procedure development, source document review, patient eligibility confirmation, patient compliance tracking, supply inventory management, adverse events reporting, regulatory compliance monitoring, and regulatory documentation maintenance.

We have a vast database of investigators and site associations to ensure rapid identification of potential investigators and their patient populations to help ensure enrolment goals are met. We also train investigators and site teams on protocol requirements, industry best practices, and technology tools, such as electronic data capture.

 

 

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Across all research, our Project managers deliver solution-focused project management. They are a single point of contact with therapeutic equivalency knowledge. They provide valuable insight into your recruitment issues, assess the impact of competitive trials, and improve patient access and retention. They offer responsibility and transparency, as well as a proven track record of effective performance. Timelines and risks are managed proactively, applying knowledge from past experiences to enable efficient study management.

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Dermatology

ICBio has experience in conducting transdermal patch studies, bioequivalence studies with pharmacokinetic (PK) outcomes and adhesion tests, skin irritation studies, and Proof of Procedure. A proof-of-concept research was conducted on healthy adult human volunteers to assess skin irritancy parameters, define study obstacles, and assess the cumulative skin irritancy potential of test goods (control solutions) under occlusive patch settings.

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