Our pharmacokinetic (PK) studies in rats, mice and dogs help in understanding the characteristics of New Chemical entities (NCEs). Our PK studies are highly efficient in predicting the exposure while determining the dosage levels and frequencies for testing in preclinical in vivo animal disease efficacy models. We conduct PK studies for small and large molecules at our state-of-the-art laboratories and vivarium. Our DMPK scientists help understand the drug's AUC, clearance, half-life, the volume of distribution, Cmax, and Cmin in the body over time.
Industry’s leading CRO for Pharmacokinetic Studies A variety of surgical animal PK models Track record of delivering 200+ GLP studies GLP accredited bioanalysis labs for PK studiesNon-GLP bioanalysis facilities for PK studiesA wide range of administration routes
Why Aurigene Pharmaceutical Services?
Variety of surgical animal PK models
Track record of delivering 200+ GLP studies
GLP accredited bioanalysis labs for PK studies
Non-GLP bioanalysis facilities for PK studies
A wide range of administration routes
Other Services
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Resources
FEBRUARY 25, 2025
Transforming Drug Discovery with Aurigene.AI
In the early 2000s, developing Sovaldi, a hepatitis C treatment, took over a decade and nearly $2 billion. Similarly, Zolgensma, a gene therapy for spinal muscular atrophy, required 15 years due to its complexity. However, the advent of artificial intelligence (AI) has revolutionized drug discovery. For example, in 2022, Pfizer's PAXLOVID, an oral COVID...
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Advancement in personalized medicine and how the CRDMO industry is part of the solution
Personalized medicine is transforming the healthcare landscape by customizing treatment plans to individual patients’ unique genetic, clinical and environmental characteristics. These are effective and less invasive treatments for a wide range of conditions. Contract Research, Development and Manufacturing Organizations (CRDMOs) play an important role...
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Cell Line Development
We enable development of stable and high yielding recombinant Mammalian and Microbial lines. ...
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Familiarization, process optimization, and cGMP manufacturing and supply of 30.0 kg of a Bioactive Nucleotide (NAD Booster)
Background: A US-based biopharmaceutical company approached Aurigene Pharmaceutical Services for the familiarization, process development, and cGMP manufacturing and supply of 30.0 kg Nucleotide product (NAD booster) for phase-appropriate studies. The synthesis of the desired product involves three linear stages, which starts with reaction of a pentose...
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Identification of Degradants of Thermal and Oxidation Stress Studies of Empagliflozin and Linagliptin Tablets by HPLC-PDA and LC-MS Instrumental Techniques
2022
Objective of the manuscript is to identify the degradants observed in the thermal and oxidation degradation sample of Empagliflozin and Linagliptin tablets by using LC-MS and HPLC-PDA instrumental techniques. Thermal and oxidation degradation samples were injected in HPLC-PDA and LC-MS instruments. Mass of the degradants were detected by LC-MS technique, ...
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Discovery of MAP855, an Efficacious and Selective MEK1/2 Inhibitor with an ATP-Competitive Mode of Action.
2005
Mutations in MEK1/2 have been described as a resistance mechanism to BRAF/MEK inhibitor treatment. We report the discovery of a novel ATP-competitive MEK1/2 inhibitor with efficacy in wildtype (WT) and mutant MEK12 models. Starting from a HTS hit, we obtained selective, cellularly active ...
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Wang-OSO3H catalyzed green synthesis of bioactive isoindolo[2,1- a ]quinazoline-5,11–dione derivatives: An unexpected observation
2005
The sulphonic acid-functionalized Wang resin (Wang-OSO3H) was explored as a polymeric and recov- erable acidic catalyst for the synthesis of isoindolo[2,1- a ]quinazoline-5,11–dione derivatives under green conditions. Thus the Wang-OSO3H ...
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Polycyclic Aromatic Compounds: A Simple and Efficient [(n-Bu3Sn)2MO4]n Catalyzed Synthesis of Quinazolinones and Dihydroquinazolinones
2005
A novel unprecedented approach for the synthesis of various quinazolinones and dihydroquinazolinones has been using [(n-Bu3Sn)2MO4]n as a catalyst. The reaction has been screened ...
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Frequently asked questions
What are some common challenges faced during in vivo pharmacokinetics (PK) studies?
Some major challenges during in vivo pharmacokinetic (PK) studies are optimization of new drug entities for their appropriate ADME studies and improper in vitro analysis giving inaccurate results. In addition, inaccuracies in tissue biopsy analysis can pose challenges, which can lead to erroneous data on tissue drug distribution during PK studies. The other critical challenges include the safety and efficacy of the drug that can affect patient response as well as physiological and pathological processes, influencing the PK studies.
How are in vivo pharmacokinetics studies conducted in Aurigene Pharmaceutical Services?
At Aurigene, we efficiently perform the PK studies corresponding to preclinical in vivo testing using animal modalities. With the state-of-the-art infrastructure and GLP- accredited bioanalysis laboratories, PK studies of the potential drug are conducted through characterization procedures and ADME parameters. The exposure, dosage levels, and preclinical testing are conducted via blood and urine samples depending upon the single or repeated dose. A wide range of administration routes are studied to optimize the drug dosage and drug delivery. The various other pharmacokinetic services include half-life determination, volume of distribution analysis, and drug clearance assessment.
How are dog PK studies conducted in Aurigene Pharmaceutical Services?
At Aurigene, in vivo PK studies are conducted on rats, mice, and beagle dogs. These studies provide a deeper understanding of the pharmacological profile and action of potential new chemical entities or candidate drugs. The PK studies involve the validation and assessment in terms of exposure limits, dosage level, frequency, bioavailability and multidose safety studies in beagle dogs for the preclinical testing. Our in vivo PK studies in dogs are highly efficient in predicting the exposure while determining the dosage levels and frequencies for preclinical testing.
How are pharmacokinetic parameters calculated in dog PK studies in Aurigene Pharmaceutical Services?
Pharmacokinetic studies in animals involve the assessment and validation of the critical parameters on ADME studies. It substantiates the collective data regarding the clearance studies, half-life, bio availability, volume of distribution, and protein drug interactions. The in vivo PK studies in dogs, rats, and mice provide valuable insights into the characteristic nature of new chemical entities (NCEs). At Aurigene, PK studies conducted are highly efficient in determining exposure and dosage levels and frequencies in preclinical testing for in vivo animal disease efficacy models.
Does APSL perform analytical method development in order to ensure that the analytical method is “stability-indicating”?
Stability indicating nature of analytical method will be demonstrated during analytical method development of drug substance related substances and assay method. To demonstrate the stability indicating nature of analytical method, degradation samples shall be generated by stressing the test sample with acid, base, water hydrolysis, oxidative, thermal and photostability study . The degraded sample shall be analyzed and demonstrated the separation of degradation impurities from known impurities and analyte peak. Photostability study shall be carried out as per ICH QIB.
What are the different types of in vivo pharmacokinetics studies conducted in Aurigene Pharmaceutical Services?
PK studies determine the exposure and dosage levels and frequencies for testing in preclinical in vivo animal disease efficacy models. At Aurigene, PK services are offered using advanced technological expertise. We conduct PK studies for small and large molecules in the laboratories and vivarium. We measure pharmacokinetic parameters such as area under the curve (AUC), drug clearance, half-life, volume of distribution, maximum concentration (Cmax), and minimum concentration (Cmin) in the body over time.
Further, at Aurigene, pharmacokinetic studies are conducted in rodents or mice using single or multiple doses. Micro-sampling, dose escalation studies, tissue distribution, brain penetration, pharmacokinetic studies in the spinal cord and CSF, and excretion studies are also performed.
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