
Service
Bioequivalence &
Pharmacokinetics
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.
Equilab International as the first and the leading Bioequivalence Center in Indonesia, Equilab has 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 Bioavailability/Bioequivalence studies in healthy volunteers
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Bioequivalence studies on special populations (i.e., post-menopausal women, diabetic patients, cancer patients)
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Biosimilar studies (i.e., Somatropin)
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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

Bioavailability / Bioequivalence Studies in Patient
On drugs with safety concerns if conducted in healthy volunteers, Bioavailability/Bioequivalence Studies should be conducted using special populations. Indonesia is one of the most populous countries with variety of disease prevalence and it can expedite subject recruitment process.
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

Complex Dosage Form
With our experience in Bioavailability/Bioequivalence studies for a wide range of therapeutic areas, we provide expert services in handling various dosage forms, including:
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Solid oral dosage forms including modified release, such as: Extended Release, Delayed Release, Sustained Release, Oral Dispersible Tablet
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Liquid oral formulations, such as: dry suspension
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Parenteral formulations
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Microneedle patch
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Suppositories
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Long acting subcutaneous injectable
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Long acting intramuscular injectable
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Long acting implant

Biosimiliar
Supported by our facilities and instruments, we also have successful experiences in conducting bioequivalence studies on biosimilar products, such as 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.

Moreover, Somatropin also comes in a complex dosage form and it has a relatively LLOQ which requires highly sensitive analytical techniques for quantification. Our team and instruments are capable of delivering accurate and reliable data despite these challenges.
Our experiences in conducting bioequivalence studies on biosimilar products have established us as a reliable partner from Indonesia and international customers. We offer services focused on the development and commercialization of biosimilar therapies, emphasizing quality and cost-effectiveness.
Case Study

Suppositories
We have numerous experiences in conducting Bioequivalence studies in various dosage forms, including Ketoprofen and Paracetamol suppository. Our skilled clinical team has specialized expertise in handling suppositories, ensuring precise administration and accurate data collection during the study.
Our expertise in this area shows our capability in delivering accurate and reliable data despite the complex dosage forms that require special handling methods.

Etonogestrel
We have conducted bioequivalence study for Etonogestrel implant involving 108 subjects with 3 years implant treatment. Etonogestrel also requires a very low Lower Limit of Quantification (LLOQ) at 0.03 ng/mL which require advanced analytical instrument.
This experience shows our capability to manage a large number of subjects, maintaining their compliance over an extended period of study, and develop advanced bioanalytical method.
Moreover, the positive results obtained from this study shows the effectiveness and safety of the Etonogestrel implant, contributing valuable insights to the field of contraceptive research and clinical practice.
Progesterone
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 needs 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.

Semaglutide
Semaglutide is a GLP-1 agonist that works by increasing insulin release, lowering the amount of glucagon released, delaying gastric emptying, and reducing appetite.
Equilab has successfully conducted BE studies for Semaglutide in both healthy and diabetic patients with a very fast recruitment process. Our bioanalytical method for Semaglutide has been validated using LCMS/MS.
Our highly skilled team supported by our advanced equipment enables precise measurement and analysis, providing customers with accurate and reliable data for demonstrating the similarity between their product and the reference.


As a reputable bioequivalence center in Indonesia and South East Asia, we always aim to meet the highest standards of regulatory compliance and meet customer satisfaction.