Bioequivalence Study

A day in a life of TAAB!

Lifecycle of Bioequivalence Study

• Bio-analysis of the drugs and active metabolite is an most important part of the drug development process.

• We can evaluate the potency or efficacy of the drug molecules by performing Bioavailibility/Bioequivalence Studies.

• The analysis of the drug into plasma concentration is an important tool to get a dug concentration time profile plot which give us different important pharmacokinetic parameters (PK) like Cmax, Tmax, AUCo-t, AUCo-infinity, t1/2 and Kel.

• To understand the biological action of the drug and its metabolite the importance of the PK parameters are beyond any doubt.

LC-MS/MS at Taab

LC-MS/MS I
API 2000
Model No: B7810502

LC-MS/MS II
API 1445
Model No: 009002PL

LC-MS/MS III
API 4000
Model No: V21410711

LC-MS/MS IV
API 4000 QTRAP
Model No: AR23540901

LC-MS/MS V
API 4000
Model No: V26771002

A journey...

• From the beginning to till date, a huge no of drugs molecules have been analyzed by the suitable, sensitive, selective, rapid, reproducible and high throughput LC-MS/MS methods in plasma.
  In this way, we have already analyzed more than 500 drugs molecules by LC-MS/MS methods in human plasma.

• Recently, we have quantified Voglibose in femtogram level (concentrations) by LC-MS/MS API 4000 QTRAP in human plasma.

• In last few months, we did bioanalysis of several FDC molecules. It was very challenging for us. Some of them were analyzed in different polarity either positive or negative in different methods. Such as Sitagliptin+Metformin+Dapagliflozin, Sitagliptin+Metformin+Glimepiride, Sitagliptin+Metformin+Pioglitazone, Teneligliptin+Pioglitazone+Metformin, Metformin+Glimepiride+Voglibose, Chlorthalidone+Metoprolol+Telmisartan,Vildagliptin+Metformin,Acotiamide+Pantoprazole, Bilastine+Montelukast etc.

• We have also analyzed some hormonal drugs like Progesterone, Estradiol, Estrone etc. in a very low dose and measured in pictogram (pg) to nanogram (ng) levels in human plasma.

Enormous possibilities in
LC-MS/MS

Forensic Science
1.Identify various illicit drugs in biological and chemical matrices
2. Dyes in fibers as trace evidence ( fibre in carpet, polymer in paint)
3. Fire debris from a particular crime scene ( arson investigation) and ballistics
4. Confirmation of drug abuse
5. Identification of explosives residues( bombing investigation)
6. Drug testing and DNA analysis by dried blood spot method
7. DNA analysis
8. Fingerprint analysis
9. Blood stain pattern analysis
10. Chemical analysis of drugs

Environmental Science
1. Drinking water testing
2. Pesticides residues screening and quantitation
3. Soil contamination assessment
4. Carbon dioxide and pollution monitoring
5. Trace elemental analysis of heavy metal leaching
6. Elemental assay of bleaching powder

Food Science
1. Pesticides residues
2. Food additives
3. Composition analysis of wine
4. Identification of alfatoxins in food
5. Determination of vitamin D3 in food supplements
6. Vitamin and protein analysis from blue green algae ( treating high blood pressure and as a protein supplement)
7. Analysis of ingredients in tomato sauce

Pharmaceutical, Biochemical and Clinical Studies
1. Pharmacokinetics study
2. Metabolomic study
3. Proteomics study ( Enzyme, DNA, RNA, peptides, biomarkers analysis)
4. Lipidomic study
5. Steroids analysis
6. Gel analysis
7. Bioeqivalence study
8. Drug molecular structure analysis (drug discovery)
9. Toxicological study
10. Dissolution study
11. Amino acids analysis
12. Urine, CSF analysis
13. Sputum analysis
14. Antigen and antibody analysis
15. Hormone analysis

Text in purple denotes, tests/studies been conducted in Taab!