PKI Studies Conducted
BioPharma Services has completed a wide range of Protein Kinase Inhibitor (PKI) Studies. Understand our experience below.
At BioPharma Services, we offer expertise in the execution and analysis of Pharmacokinetic Studies. These are investigations designed to assess how different drugs interact within the body, and how those interactions may influence drug metabolism and effects. Our comprehensive PK studies provide crucial insights into pharmacokinetics that can provide further assessment on comparability bioavailability, safety and efficiency.
We have diverse experience in most therapeutic areas and different drug classes, including antineoplastic agents. The kinase inhibitors – protein kinase inhibitor (PKI), are a large group that specifically targets protocol kinases activities, which are involved in many important cell functions such as cell signalling, growth and division. Multiple PKIs have been introduced since the last 20 years, providing patients with more treatment options with higher efficiency and lower risk profiles. We are adept at performing PK studies with PKI agents in normal, healthy volunteers. Our meticulous and rigorous evaluation process has resulted in numerous PKIs being reviewed and deemed acceptable to dose in normal, healthy volunteers.
BioPharma Services’ expertise in these areas assures our global drug development clients of our ability to generate reliable and high-quality data, ultimately accelerating the drug development process, minimizing risks, and improving the potential for regulatory success.
TKIs & Designs for Studies in Normal Healthy Volunteers
RLD | TKIs | BE Study Design (Both Fast & Fed) |
---|---|---|
Calquence® | Acalabrutinib | Single dose, 3-way crossover pilot |
Gleevec® | Imatinib | Single dose (400 mg), 2-way crossover |
Ibrance | Pabociclib | Single dose (125mg), 2-way crossover |
Imbruvica® | Ibrutinib | Single dose (560 mg), 4-way fully replicate |
Inlyta® | Axitinib | Single dose (5 mg), 3-way partial-replicate |
Iressa® | Gefitinib | Single dose (250 mg), 2-way crossover and 4-way fully replicate |
Kisqali® | Ribociclib | Single dose (200 mg), 3-way crossover (pilot) |
Lenvima® | Lenvatinib | Single dose 10 mg, (4-way fully replicate) |
Nerlynx® | Neratinib | Single dose (240mg), 3-way crossover pivotal |
Nexavar® | Sorafenib | Single dose (200 mg), 2-way crossover and 4-way fully replicate |
Sprycel® | Dasatinib | Single dose (100 mg or 140 mg), 4-way fully replicate |
Stivarga® | Regorafenib | Single dose (40 mg), 2-way crossover |
Sutent® | Sunitinib | Single dose (50 mg), 2-way crossover |
Tarceva® | Erlotinib | Single dose (150 mg), 2-way crossover |
Votrient® | Pazopanib | Single dose (400 mg), 2-way crossover and 4-way fully replicate |
Xeljanz® | Tofacitinib | Single dose (5mg), 2-way crossover |
Zydelig® | Idelalisib | Single dose (150mg), 2-way crossover |
Rydapt® | Midostaurine | Single dose (25 mg), parallel |
PKIs Reviewed & Deemed Acceptable to Dose in Normal Healthy Volunteers
Brand Name | Active Ingredient |
---|---|
Albunbrig | Brigatinib |
Alecensa | Alectinib Hydrochloride |
Ayvakit | Avapritinib |
Balversa | Erdafitinib |
Bosulif | Bosutinib Monohydrate |
Brukinsa | Zanubrutinib |
Cabometyx tablet | Cabozantinib S-Malate |
Calquence | Acalabrutinib |
Caprelsa | Vandetanib |
Cometriq capsule | Cabozantinib S-Malate |
Cotellic | Cobimetinib Fumarate |
Dabrafenib* | Tafinlar |
Erivedge | Vismodegib |
Gilotrif | Afatinib Dimaleate |
Gleevec | Imatinib Mesylate |
Ibrance | Palbociclib (CDKI) |
Iclusig | Ponatinib Hydrochloride |
Idhifa | Enasidenib |
Imbruvica | Ibrutinib |
Inlyta | Axitinib |
Inrebic | Fedratinib hydrochloride |
Iressa | Gefitinib |
Jakafi | Ruxolitinib Phosphate |
Kisqali® | Ribociclib |
Lenvima | Lenvatinib Mesylate |
Midostaurin | Rydapt |
Nerlynx | Neratinib |
Nexavar | Sorafenib Tosylate |
Ofev | Nintedanib Esylate |
Olumiant | Baricitinib |
Rinvoq | Upadacitinib |
Rozlytrk | Entrectinib |
Sprycel | Dasatinib |
Stivarga | Regorafenib |
Sutent | Sunitinib Malate |
Tagrisso | Osimertinib Mesylate |
Tarceva | Erlotinib Hydrochloride |
Tasigna | Nilotinib Hydrochloride Monohydrate |
Tavalisse | Fostamatinib |
Trametinib* | Mekinist |
Turalio | Pexidartinib hydrochloride |
Votrient | Pazopanib Hydrochloride |
Xalkori | Crizotinib |
Xeljanz | Tofacitinib Citrate |
Zydelig® | Idelalisib |
Zykadia | Ceritinib |
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