Explore our collection of ready-to-use bioequivalence study protocols designed to accelerate generic drug development. Each protocol meets FDA and EMA requirements with detailed study designs and methodologies tailored to specific molecules.

Brivaracetam: It is a second-generation antiepileptic drug approved for the treatment of partial-onset (focal) seizures. It is characterized by rapid absorption, linear pharmacokinetics, and a short elimination half-life, making it well-suited for single-dose crossover bioequivalence studies. Establishing bioequivalence is crucial for supporting generic development and expanding access to cost-effective treatment options. Our ready-to-use bioequivalence study protocol for brivaracetam is developed in alignment with FDA Product-Specific Guidance, ICH E6 (R3) GCP, and EMA requirements, providing a regulatory-ready study design with defined pharmacokinetic, statistical, and safety frameworks to support efficient ANDA and global generic submissions.

Ivabradine Hydrochloride: It is a selective heart rate-lowering agent used to manage stable angina and chronic heart failure. Its predictable pharmacokinetics and well-understood safety profile make it an ideal candidate for bioequivalence studies, supporting the development of reliable generic alternatives. Our ready-to-use bioequivalence study protocol provides a fully regulator-aligned framework for study design, pharmacokinetic assessment, and safety monitoring, helping streamline study setup and accelerate regulatory submissions, ultimately supporting wider patient access to this important therapy.

Emtricitabine / Tenofovir: It is a widely used antiretroviral combination for HIV-1 treatment and PrEP, offering proven efficacy and improved renal and bone safety compared with older tenofovir formulations. With rapid absorption and predictable pharmacokinetics, it is well-suited for bioequivalence evaluation. Our ready-to-use bioequivalence study protocol offers a practical, regulator-ready roadmap for study design, pharmacokinetic assessment, and safety monitoring, designed to make study execution smoother and help bring safe, affordable generics to patients faster.

Sacubitril / Valsartan: It is a proven angiotensin receptor-neprilysin inhibitor (ARNI) used in chronic heart failure, combining sacubitril and valsartan to support heart function while reducing cardiovascular risk. Our ready-to-use bioequivalence study protocol offers a clear, practical framework for pharmacokinetic assessment, safety monitoring, and study execution, helping sponsors efficiently generate reliable BE data. By enabling accurate evaluation of absorption and exposure, the protocol supports regulatory submission and facilitates the development of affordable generic alternatives, ultimately improving patient access to this important therapy.

Tapentadol Hydrochloride: It is a centrally acting opioid analgesic indicated for the management of severe, persistent pain and neuropathic pain associated with diabetic peripheral neuropathy. Our ready-to-use bioequivalence study protocol provides a practical framework to assess the pharmacokinetics and safety of Tapentadol ER formulations, helping sponsors efficiently generate reliable BE data. By supporting precise evaluation of absorption and systemic exposure, the protocol facilitates regulatory submission and the development of safe, effective generic alternatives, ultimately improving access to pain management therapies while maintaining established safety standards.

Lenvatinib Mesylate: It is a multitargeted tyrosine kinase inhibitor used for the treatment of advanced cancers, including radioactive iodine-refractory differentiated thyroid cancer, renal cell carcinoma, hepatocellular carcinoma, and endometrial carcinoma. It works by selectively inhibiting VEGF receptors and other kinases, helping to slow tumor growth and progression. Our ready-to-use bioequivalence study protocol provides a structured framework to evaluate Lenvatinib’s pharmacokinetics, leveraging its well-characterized absorption, high bioavailability, and relatively long half-life for precise and reliable PK assessment. By supporting efficient generation of BE data, the protocol helps facilitate regulatory submissions and the development of safe, effective generic alternatives, ultimately improving access to advanced oncology therapies.

Lurasidone Hydrochloride: It is an atypical antipsychotic approved for the treatment of schizophrenia and depressive episodes associated with Bipolar I Disorder in adults and adolescents. With a well-characterized pharmacokinetic profile, including moderate bioavailability enhanced by food and a half-life of approximately 18–20 hours, it offers predictable absorption and metabolism. Our ready-to-use bioequivalence study protocol is designed to generate robust PK data for generic development, supporting regulatory submissions and helping bring safe, effective alternatives to patients in need.

Fostamatinib Disodium: It is a spleen tyrosine kinase (Syk) inhibitor approved for the treatment of chronic immune thrombocytopenia (ITP) in adults who have not responded adequately to prior therapies. By targeting antibody-mediated platelet destruction, it offers a differentiated mechanism of action in a patient population with limited options. With predictable, linear pharmacokinetics and a well-defined safety profile, fostamatinib is well-suited for bioequivalence evaluation. Our ready-to-use BE study protocol is aligned with FDA guidance, focuses on the active metabolite R406, and supports efficient generic development while helping expand access to this important therapy for patients with refractory ITP.

Rivaroxaban: It is a direct factor Xa inhibitor widely used in the prevention and treatment of thromboembolic disorders, including stroke prevention and venous thromboembolism. The oral suspension formulation addresses important clinical needs in patients who have difficulty swallowing tablets, such as pediatric or dysphagic populations. With rapid absorption, predictable pharmacokinetics, and a well-established safety profile, rivaroxaban is well-suited for bioequivalence evaluation. Our ready-to-use BE study protocol is developed in line with current FDA guidance, incorporates an appropriate replicate design to address variability, and supports efficient generic development while helping expand access to flexible anticoagulant therapy options.

Tofacitinib Citrate: It is an orally administered Janus kinase (JAK) inhibitor approved for the treatment of rheumatoid arthritis and other immune-mediated inflammatory conditions in patients with an inadequate response to prior therapies. By offering an effective oral alternative to injectable biologics, it improves treatment convenience and flexibility. Tofacitinib has rapid absorption, a short half-life, and well-characterized pharmacokinetics, making it well-suited for bioequivalence evaluation. Our ready-to-use BE study protocol is developed in line with current FDA guidance and supports efficient generic development, helping broaden access to established targeted therapies in autoimmune disease management.