Syngene JSS AHER Certificate Program in Drug Metabolism and Pharmacokinetics (DMPK)

Biocon Academy with Syngene International partners with JSS Academy of Higher Education and Research (formerly JSS University), a leading institute of higher education and a deemed-to-be university recognized by the MHRD and accredited by NAAC with an A+ grade, to deliver a first-of-its-kind Certificate Program in Drug Metabolism and Pharmacokinetics (DMPK).

Program Highlights

This 16-week Advanced Certificate Program in DMPK is designed to prepare postgraduates in chemistry, biochemistry, and pharmacy with cutting-edge knowledge and hands-on skills essential for careers in pharmacokinetics, pharmacodynamics, and translational research through an intensive curriculum delivered by the renowned faculty from JSS AHER, Mysore and Subject Matter Experts from Syngene International limited.

Career Opportunities

A DMPK professional is expected to be well-versed in advanced PK and DMPK principles, Skilled in using bioanalytical tools and interpreting complex PK/PD data and Industry-ready for roles in R&D, clinical pharmacology, regulatory affairs, and bioanalytics.

Customised Curriculum

This intensive training program bridges academic knowledge with industrial application through an integrated curriculum delivered by experience Faculty from JSS AHER, experiential learning at Syngene DMPK facility and practical exposure

Key Differentiators

First of its kind program in niche area like drug metabolism and pharmacokinetics
Versatile pedagogy including classroom sessions, experiential learning, hands on experience and simulations catering to students with different learning styles and needs
Leverages the strength of experienced faculty and state of the art DMPK facility of JSS AHER and Syngene to unleash the learning opportunities to the participants
Dedicated focus on professional skills development specifically for those who would be working in intense research environments

Course Modules

Introduction to Drug Discovery

Basic practice & instrumentation

Introduction to Discovery Biology R&D
Autoclaving, Dry heat sterilization, Pipettes, pH meter-Calibration, usage
Other equipment’s: Microscopes, shakers, heating blocks, freezers, CO2 incubators, Shaker incubators
Centrifugation: Principle, Calculation of g & rpm conversion, Balancing, Precautions, Tabletop, Floor model and ultra centrifuge

Basic calculations & techniques

Basic Calculations- Molarity, Molality, Buffer preparation
Biochemical assays- Lowrey, Bradford, BCA, DNA estimation
Agarose Gel electrophoresis, SDS-PAGE, Western Blotting, Southern blotting, Northern blotting, PCR, RT-PCR

Overview of DMPK

Principles of pharmacokinetics: ADME overview
Importance of DMPK in drug discovery and development
Differences between preclinical and clinical PK
Species selection and translational relevance
Regulatory perspectives (FDA, EMA guidelines)

Documentation practices and safety measures

Good documentation practice, data integrity, ALCOA+ principles
Documentation- Book writing and data entry, storage of raw data
SOPs, EOPs, IOPs- what are they and basic rules
EHS, Safety, Lab Rules

Invitro Stability and Enzyme Kinetics

Liver microsomes, S9 fraction and hepatocyte assays, Intrinsic clearance, Half-life determination
Scaling in-vitro to in-vivo (IVIVE)
CYP450 isoform identification
Inhibition assays (reversible and time-dependent), Induction studies
Drug-drug interaction risk assessment

Plasma and Microsomal Protein Binding

Equilibrium dialysis, ultrafiltration, ultracentrifugation
Impact of protein binding on drug exposure

Permeability and Transporter Assays

Caco-2, MDCK cell models
PAMPA
Efflux Transporter Studies (P-gp, BCRP), Uptake and Efflux Transporter Assays
Regulatory requirements for transporter studies

In Vivo Study Design and Animal Welfare

Overview of in-vivo pharmacokinetic study design
Animal care and handling
Good laboratory practice

Dose Route Selection, Sampling Techniques

Routes of administration: IV, PO, SC, IM, etc.
Formulation considerations, Single vs multiple dosing, Dose selection rationale
Blood, plasma, tissue, urine, and feces sampling
Serial vs composite sampling

Bioanalytical method development and validation

Overview and bioanalysis using LC-MS/MS
Mobile phase preparation, stock preparation and dilution.
Samples preparation techniques (Protein precipitation, liquid-liquid extraction, solid phase extraction, dispersive liquid-liquid micro-extraction etc.)
Quality control in sample handling

Pharmacokinetic Parameters and Analysis

Pharmacokinetic parameters; Cmax, Tmax, AUC, CL, Vd, t½
Non-compartmental analysis (NCA)
Compartmental models (1-compartment, 2-compartment)
Software tools (Phoenix WinNonlin, PKSolver)

Bioavailability and Bioequivalence

Absolute and relative bioavailability
IV-oral comparison
Bioequivalence criteria and studies

Tissue Distribution and Imaging

Methods for evaluating tissue distribution (QWBA, PET, LC-MS/MS)
Blood-brain barrier and CNS exposure
Volume of distribution and tissue binding

Clearance Mechanisms and Routes of Elimination

Hepatic and renal clearance
Biliary excretion
In-vivo metabolism studies
Mass balance and excretion profiling

Data Analysis and Software Tools

PK modeling and simulation tools (Phoenix WinNonlin, GastroPlus, Simcyp)
Data interpretation and decision-making in lead optimization

Soft Skills Intervention

Professional development sessions will be held every Friday to equip participants with:

Scientific communication
Presentation skills
Teamwork
Critical Thinking
Conflict resolution & Problem-solving workshops
Research ethics
Workplace etiquette
Resume writing and interview preparation

Eligibility Criteria

Education Qualification:

M Pharm (all streams)
M Sc Biotechnology / Biochemistry / Chemistry

Minimum CGPA/Percentage Required:

CGPA: 6.8 or above on a scale of 10
Percentage: 65%

Adherence to the eligibility criteria is mandatory. Kindly note the same and apply only if you fit the desired eligibility criteria as mentioned above.

Program Fee & Scholarship

The Biocon Merit Scholarship of 60%-75% of the program cost offered to all selected students will enable them to pursue this one-of-its-kind program at an affordable cost.

Student share: INR 50,000 + 18% GST

Student Facilities

At Biocon Academy, the students have to go through a rigorous curriculum so that by the time their course comes to an end, they are industry-ready and sought after by multiple companies. We encourage them to remain focussed and excel in everything they do. For the benefit of the students, we assist them with a couple of facilities to ensure they just focus on the curriculum.

Industry Placements

At Biocon Academy, we provide 100% interview opportunities to all our students. Ever since inception, Biocon Academy has witnessed 100% placement record in all the courses and batches with students being selected for leading pharma and biopharma companies and startups.

Transport

We understand that commuting to different locations for industry training can get challenging especially when students have to arrange for it themselves. Therefore, students are provided with group transport facilities from Biocon Academy to different training locations and then back to the Academy.

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Syngene JSS AHER Certificate Program in Drug Metabolism and Pharmacokinetics (DMPK)

Syngene JSS AHER Certificate Program in Drug Metabolism and Pharmacokinetics (DMPK)