bring your diabetes productinsulin injection r 40 iu/ml insulin aspart regular insulin human, 30 iu...
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About Navitas Life SciencesNavitas Life Sciences delivers platform-driven full-service Clinical, Regulatory and Safety solutions and services. As the dedicated life sciences brand of TAKE Solutions, Navitas Life Sciences operates across North America, Europe, Asia pacific and Latin America. Navitas Life Sciences combines the knowledge and experience of three legacy brands - Ecron Acunova, Navitas, DataCeutics, KAI Research and Intelent. Thus, Navitas brings together the capabilities of a full-service CRO, a technology-led life sciences services provider, and expertise in analytics and data sciences to address critical challenges and drive outcomes for life sciences. Navitas Life Sciences has over 30 years of rich experience across 400+ phase I-IV clinical trials, 20+ therapeutic areas, and 40+ successful GCP/non-GCP audits. Our trial expertise is augmented by OneClinical, a platform thatdelivers trial oversight, analytics, and insights to drive successful study outcomes.
For more informationAmericas +1 609 720 1002 Europe +49 69 668 0300 APAC +91 44 4590 9000 [email protected] www.navitaslifesciences.com /company/navitas-life-sciences
Diabetes Drugs Coming off Patent
Levemir (Insulin Detemir Recombinant) Afrezza (Insulin
Recombinant Human)
Actoplus Met XR (Metformin Hydrochloride; Pioglitazone Hydrochloride)
Apidra (Insulin Glulisine Recombinant)
Janumet (Metformin Hydrochloride; Sitagliptin Phosphate)
Janumet XR (Metformin Hydrochloride; Sitagliptin Phosphate)
Kombiglyze XR (Metformin Hydrochloride; Saxagliptin Hydrochloride)
Synjardy XR (Empagliflozin; Metformin Hydrochloride)
Jentadueto (Linagliptin; Metformin Hydrochloride)
Jardiance (Empagliflozin)
Glumetza (Metformin Hydrochloride)
Synjardy (Empagliflozin; Metformin Hydrochloride)
Glyxambi (Empagliflozin; Linagliptin)
Insulin - LC/MS/MS 0.2-20 ng/mL - Injection
C-Peptide - ECLIA 0.188-7.050ng/mL
Metformin - LC/MS/MS 3-2000 ng/mL & 20-2000 ng/mL - PlasmaInsulin - LC/MS/MS 0.2-20 ng/mLC-Peptide - ECLIA 0.188-7.050ng/mLPioglitazone Method can be developed and validated upon request
Metformin - LC/MS/MS 3-2000 ng/mL & 20-2000 ng/mL - Plasma
Metformin - LC/MS/MS 3-2000 ng/mL & 20-2000 ng/mL - Plasma
Saxagliptin Method can be developed and validated upon request
Empagliflozin - LC/MS/MS 5-1000 ng/mL Plasma
Metformin - LC/MS/MS 3-2000 ng/mL & 20-2000 ng/mL - Plasma
Linagliptin Method can be developed and validated upon request
Other Diabetic Methods (Analyte and Method):
2019
2021 2023
2022 2025
Brand N
ame and M
oleculeN
avitas Life Sciences’ C
urrently Available Methods
Navitas Life Sciences has the capabilities and resources to enable biosimilars companies to bring effective
ANTI-DIABETIC THERAPIESto the market quickly and safely
Navitas Life Sciences Capabilities
OUR STUDYEXPERIENCE
INCLUDES
Experienced expert Physicians from the tertiary care hospital
In-house expertise in designand conduct
Trained investigators and nursing staff
Qualified, 21CFR Part11 Compliant analyzer with redundancy
Study Conduct
BioanalysisHigh sensitivity methods
Expertise in handling peptides
LC/MS/MS Method for insulin and other peptides
ECLIA methods for Insulin and C-Peptide
With our extensive experience, we understand and have mastered the challenges of deploying the appropriate study design to effectively and scientifically demonstrate the biosimilarity of your product.
We have invested in and built up the necessary expertise and infrastructure to ensure that your
Euglycemic Glucose Clamp
BIOSIMILAR INSULIN PRODUCT is launched quickly.
Adjust Glucose Infusion to “Clamp”
Blood Glucose Levels
Frequent Blood Sampling. Heating pad to arterialise
venous blood
20% Glucose infusion through infusion pump
At “Steady-State”, Glucose Infusion = Net Glucose Utilisation
Insulin infusion if required
YSI Glucose Analyzer
Facts on Diabetes
Insulin is a hormone secreted by the
PANCREASand is responsible for modulating the use of sugars by the body.
Type 2 Diabetesis the most common type of diabetes, which occurs
when the body either becomes resistant to insulin or does not produce enough insulin, resulting in elevated
blood glucose levels.
105The WHO predicts diabetes will be the 7th leading cause of death
by 2030
Over 451 million people across the globe suffer from diabetes
In 2016,
over 5 millionpeople died due to diabetes
Hear
tBlood
vessels
Eyes
Kidn
eys NervesDiabetes
can Affect Many Parts of the Body
Diabetes is a chronic condition that is characterized by elevated levels of blood glucose
Lifestyle choices, such as diet and exercise, play a major role in causing type 2 diabetes
• Canagliflozin LC/MS/MS 25-6000 ng/mL Plasma• Glimepiride LC/MS/MS 1-200 ng/mL & 2-600 ng/mL Plasma• Glipizide LC/MS/MS 2-2000 ng/mL Plasma• Insulin & C-Peptide Antidiabetic ECLIA 0.16-7.214 ng/mL
and 0.188-7.050 ng/mL Plasma
• Insulin Glargine and M1, M2 metabolites LC/MS/MS0.2-12 ng/mL, 0.2-12 ng/mL 0.2-12 ng/mL Plasma
• Metformin & Glimepiride LC/MS/MS 10-3000 ng/mL& 2-300 ng/mL Plasma
Type 2 Diabetes68%
12%Diabeticfoot ulcer
Others*
20%
Navitas Life Sciences Diabetes Clinical Trial Experience
Soluble Insulin
Injection R 40 Iu/Ml
Insulin Aspart
Regular Insulin Human, 30 Iu per
Ml / Isophane Suspension70 Iu per Ml
Subcutaneous Doses of
Insulin Glargine Injection
Bring YourDIABETES PRODUCTto the Market Quickly and Effectively
Biphasic Isophane Insulin 30/70 Injection
200 Iu
*Includes Obesity, Prediabetes,Type 1 Diabetes
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Over 20Studies
Over 4,500patients enrolled for Studies
Over 450Sites
Glob
al
Site
Patients Enro
lled
Diab
etes
Experience Experience
Phase I
17%
Phase II
22%
Phase III
52%
Phase IV
9%
Perc
enta
ge o
f Stu
dies
Clinical Drug Development Phase Experience
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