Service
Bioequivalence &
Pharmacokinetics
Somatropin
Somatropin, as a recombinant human growth hormone, exhibits complex pharmacokinetics characterized by nonlinear absorption and distribution processes. Endogenous levels of growth hormone can vary significantly among individuals and within the same individual over time. Establishing baseline levels and accounting for this variability are critical in interpreting study results accurately.
Somatropin also comes in complex dosage forms (microneedle patches). Our clinical team is skilled in performing subcutaneous injection techniques, including the accurate use of microneedle patches. We recognize the significance of appropriate handling, positioning, and monitoring to guarantee effective delivery and therapeutic outcomes We have also successfully maintained subjects’ compliance during the clinical phase.
Furthermore, somatropin has a relatively LLOQ and requires highly sensitive analytical techniques for quantification. Notwithstanding the aforementioned challenge, our bioanalytical method has been developed to detect and quantify somatropin, thereby ensuring accurate measurement even in biological matrices with low analyte levels.
Progesterone
We have conducted a progesterone bioequivalence study with a successful result. Progesterone is an endogenous hormone that needs assessment of baseline levels to eliminate any external influences. Moreover, the challenge of progesterone is notably low Lower Limit of Quantification (LLOQ) at 0.2ng/ml underscores the need for precision and sensitivity in our Bioanalytical method.
Due to the complexities of progesterone as an endogenous substance, our team successfully ensured comprehensive and accurate results. Our facilities and our advanced instruments are also capable of overcoming these challenges.
In order to provide our clients with the best possible service, we ensured that every aspect of the study was carried out meticulously in order to deliver reliable results.
Etonogestrel
We have conducted an Etonogestrel implant Bioequivalence (BE) study with more than 100 subjects for a duration of 3 years. This experience demonstrates our capability to manage a large number of subjects over an extended period while achieving successful results.
By successfully conducting this study, it demonstrates our capability in managing a large number of subjects and maintaining their compliance over an extended period. Moreover, the positive results obtained from the study underscore the effectiveness and safety of the Etonogestrel implant, contributing valuable insights to the field of contraceptive research and clinical practice.
Suppositories
We have numerous experiences in conducting Bioequivalence (BE) studies in various dosage forms, including Ketoprofen and Paracetamol suppository. Our skilled clinical team has specialized expertise in handling these dosage forms, ensuring precise administration and accurate data collection throughout the study duration.
By paying attention to detail and adherence to stringent protocols, we have successfully managed multiple BE studies involving suppositories, demonstrating our capability to navigate the complexities of this dosage form with proficiency. Our expertise in this area demonstrates our capability in delivering accurate and reliable data despite the complex dosage forms that require special handling methods.
Case Study
Biosimiliar
Equilab's experience as a Contract Research Organization (CRO) in conducting bioequivalence (BE) studies on biosimilar products like Semaglutide has been marked by precision, expertise, and innovation.
Semaglutide comes in complex dosage forms (microneedle patches). Our teams are trained in applicating subcutaneous injection techniques, including the precise application of microneedle patches. We understand the importance of proper handling, positioning, and monitoring to ensure optimal delivery and therapeutic efficacy.
From study design to execution, our experienced team supported by highly sophisticated equipment enables precise measurement and analysis, providing clients with accurate and reliable data for demonstrating the similarity between their biosimilar products and the reference.
Our experience in conducting bioequivalence studies on biosimilar products has established us as a reliable partner for pharmaceutical companies. We offer services focused on the development and commercialization of biosimilar therapies, emphasizing quality and cost-effectiveness.
Throughout the entire process, we emphasize adherence to regulatory guidelines and best practices, ensuring that studies are conducted with the highest standards of quality and integrity according to GCP.
Complex Dosage Form
With our experience in BE studies for a wide range of therapeutic areas, we provide expert services in handling various dosage forms, including:
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Solid & Liquid oral formulations [Tablets (Immediate release & modified release, e.g., ER, DR, SR, ODT), capsules, soft gels, solutions.]
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Parenteral formulations
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Topical transdermal products (microneedle patches)
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Suppositories
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Long acting injectable
BA/BE Studies in Patient
The subject population for bioequivalence studies should be selected with the aim of permitting the detection of differences between pharmaceutical products. On drugs that carry safety concerns in healthy volunteers, BA/BE Studies will be conducted using special populations.
We have experience in conducting BA/BE studies in:
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Hormonal drug for postmenopausal women
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Diabetic drug for diabetic patients
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Anti-cancer drug for prostate cancer patients
Overview
Equilab provides leading bioequivalence services with efficient and comprehensive support for our clients with their bioequivalence and bioavailability studies and the development of generic products.
We have completed over 1200 projects, and our study reports have been accepted in more than 40 countries, including regulatory bodies such as WHO, UK-MHRA, and NPRA
Our experiences including:
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Single and multiple-dose BA/BE studies in healthy volunteers
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Studies on special populations (i.e., post-menopausal women, diabetic patients, cancer patients)
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Studies on biosimilar products
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Various dosage forms, i.e., tablets, capsules, solutions, microneedle patches, implants, suppositories, and parenteral formulations
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We have developed and validated more than 250 bioanalytical methods in compliance with current international regulatory requirements and guidance