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SAFE Laboratory
Biological Sample Analysis Laboratory
Biological Sample Analysis Laboratory
SAFE Pharmaceutical Bioanalytical Laboratory has systematically carried out pharmacokinetic evaluation research on all kinds of innovative drugs according to the requirements of national new drug registration regulations and relevant technical guidelines. The research scope mainly includes: chemical drugs, biotechnology drugs, traditional Chinese medicines and natural drugs. In addition, SAFE has cooperated extensively with clinical research institutions to do generic drug consistency evaluation BE trial and innovative drugs phase I clinical pharmacokinetic research and has the ability to conduct research in compliance with GLP/GCP standards. Registration application and evaluation services and consultation services in accordance with NMPA, OECD, FDA and other relevant technical standards can be provided according to the needs of customers for new drug research and development.
Non-clinical pharmacokinetic studies of innovative chemical/biotech drugs/ traditional Chinese medicines/natural medicines

Program design and method development
• New drugs development goals and registration
• Analytical methods for drugs and metabolites in biological samples
• In vivo/in vitro enzymatic/cell based pharmacokinetics to determine the targeted composition in cell by mass spectrometry using radioisotope tracer technology.
• Drug permeability and absorption mechanism
• Metabolic stability of drugs in plasma/enzyme and cell of different species
• Identification of metabolite(s)of drug and its metabolic pathway
• Enzyme phenotype studies of drug metabolites
• Induction/inhibition of drug-metabolizing enzymes
• Drug-drug interaction

Pharmacokinetic research on whole animal levels
Animal absorption, distribution, excretion characteristics and material balance under different dosing routes in animals
• Plasma protein binding study on different species
• Pharmacokinetic process simulation / parameter calculations
• Non-analytical PK/PD/Tox correlation of NCE

Non-clinical pharmacokinetic research on modified chemical/biotech drugs/Chinese medicines and natural medicines and their formulations

Program design and method development
• New drug development goals, clinical value assessment and IND or NDA
• In vivo/in vitro exposure mass spectrometry research on modified new drugs
• Determination of target components in in vivo pharmacokinetic research

Pharmacokinetic research on modified drugs
• Prodrugs
• Salt-changing drugs
• Drug enantiomers
• Various modified formulations

Generic Conformance Evaluation / Phase I Clinical Pharmacokinetic Study
• Bioequivalence study / Phase I clinical design
• Analytical program design and method development for clinical biological samples
• Analytical testing of clinical biological samples
• Parameter calculation and statistical analysis of bioequivalence data

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