Solutions
DMPK
PharmaJen’s DMPK expertise accelerates drug discovery success. We offer comprehensive services, expert analysis, and collaborative problem-solving, enhancing molecule quality and project efficiency. Our flexible, tailored solutions cover physicochemical properties, in vitro ADME, drug-transporter studies, and in vivo pharmacokinetics across multiple species, ensuring comprehensive support throughout your drug discovery journey.
PHYSICOCHEMICAL PROPERTIES
- Solubility
- Kinetic solubility
- Thermodynamic solubility
- Lipophilicity
- Log D7.4
- Log P
- pKa
- Stability in buffers or biological fluids
IN VITRO ADME
Absorption Studies
- Caco-2 (unidirectional or bidirectional, with/without inhibitors)
- MDCK-MDR1
- PAMPA (Parallel artificial membrane permeability assay)
Distribution Studies
- Plasma protein binding
- Brain/Liver homogenate binding
- Microsomal protein binding
- Blood to plasma partition
Metabolism Studies
- Microsomal stability (Liver, Intestine, lung)
- S9 fractions (liver, Intestine)
- Hepatocytes (Human, Rat)
Drug-Drug Interaction (DDI) Studies
- CYP inhibition (single point/IC50)
- Time-dependent CYP inhibition (IC50/IC50 shift)
- UGT inhibition IC50 (single point/IC50)
- CYP induction
- CYP reaction phenotyping using HLM/recombinant CYPs
- UGT reaction phenotyping using HLM/recombinant UGTs
Reactive Metabolites
- Glutathione trapping method
- Cysteine trapping method
Drug Transporters Studies
- OATP1B1 / OATP1B3 / OATP2B1 / OCT1 / OCT2 / OAT1 / OAT3 Uptake Studies / Inhibition Studies
IN VIVO DMPK
In Vivo Studies
- Pharmacokinetics
- Bioavailability
- Single/multiple dosing
- Dose escalation
- Tissue distribution
- Cassette dosing
- Drug interaction studies
Species
- Rat
- Mice
- Rabbit
- Dog
Sampling Methods
- Jugular
- Femoral
- Portal vein
- Bile duct canulation
- Saphenous Vein
Chemistry
At PharmaJen, we excel in advancing your drug discovery chemistry programs. Our specialized expertise covers custom synthesis, multistep organic synthesis, and process optimization. With a focus on intellectual property protection, we navigate hit to lead and lead optimization. Our services extend to heterocyclic and asymmetric synthesis, macrocycles, and organometallic chemistry.
Partner with us for integrated drug discovery, including medicinal chemistry solutions, computer-aided drug design, exploratory candidate nomination, and focused compound library synthesis. We also offer specialty chemicals like reference compounds, deuterated compounds, and API impurities to support your research.
Custom Synthesis
- Multistep organic synthesis
- Process optimization
- Route scouting
- Heterocyclic chemistry
- Asymmetric synthesis
- Synthesis of macrocycles
- Organometallic chemistry
Integrated Drug Discovery
- Medicinal chemistry solutions
- Computer aided drug design (CADD)
- Lead generation
- Lead optimization
- Focused compound library synthesis
Speciality Chemicals
- Reference compounds
- API impurities
Bioanalysis
Explore PharmaJen’s advanced Bioanalysis service, combining cutting-edge technology with extensive expertise. We offer precise metabolite quantification for pharmacokinetics, toxicokinetics, bioequivalence, and exposure-response studies. Our UHPLC-MS/MS capabilities ensure rapid, accurate, and sensitive quantification from diverse biological matrices. With our newly acquired Nexera UHPLC-LC-40D XS coupled with SCIEX QTRAP 4500 system, we guarantee enhanced throughput and robustness, especially in metabolite identification.
PharmaJen’s Bioanalysis service covers method development and validation for small and large molecules, biotransformation, and metabolite identification, empowering your drug discovery journey.
Method development and validation
- Small molecules
- Large molecules
Biotransformation and metabolite identification
Preclinical Toxicology
Safety is the foremost criteria for any drug candidate alongside the efficacy. Accurate and reliable preclinical safety and toxicology data ensures the progress of novel chemical entities to IND filing or to clinical trials. Pharmajen’s robust and validated safety and toxicity test systems enable the accurate assessment of molecule’s safety and toxicity profile at the early stage of drug discovery. We offer a range of exploratory and non-GLP toxicology services according to the regulatory guidelines that facilitate rapid decision making for drug candidate selection.
- Cytotoxicity (cell viability/proliferation)
- Genotoxicity (mini-AMES, micronucleus test)
- Cardiotoxicity (hERG binding assay)
- In vivo toxicity (acute, sub-acute, chronic toxicity studies and maximum tolerated dose studies)
Investigational New Drug (IND) enabling studies
PharmaJen specializes in Investigational New Drug (IND) enabling studies, meticulously aligned with regulatory expectations. Our comprehensive in vitro investigations encompass a range of crucial assessments for successful IND programs. These include CYP inhibition, induction, and time-dependent inhibition studies, plasma protein binding analysis, blood cell partitioning, liver microsomal stability, hepatocyte stability assessments, CYP phenotyping studies, bidirectional permeability assays using Caco-2, P-glycoprotein inhibition studies, as well as uptake and inhibition studies for key transporters such as OATP1B1, OATP1B3, OATP2B1, OCT1, OCT2, OAT1, and OAT3.
PharmaJen ensures that your drug candidates meet regulatory requirements and advance confidently in the drug development process. The following studies are performed for successful IND programs.
- CYP inhibition
- CYP induction
- CYP time dependent inhibition
- Plasma protein binding
- Blood cell partition
- Liver microsomal stability
- Hepatocyte stability
- CYP phenotyping studies
- Bidirectional permeability assay in Caco-2 assay
- P-glycoprotein inhibition
- OATP1B1 / OATP1B3 / OATP2B1 / OCT1 / OCT2 / OAT1 / OAT3 Uptake Studies / Inhibition Studies
