|
Regulatory Affairs | Regulatory Compliance | Business Development
A key goal in pharmaceutical development of dosage forms is a good understanding of the in vitro and in vivo performance of the dosage forms. One of the challenges of biopharmaceutics research is correlating in vitro drug release information of various drug formulations to the in vivo drug profiles. However, it is not easy or inexpensive to try to determine a correlation. Fortunately, pharmaceutical and pharmacokinetic experts can use their experience to predict the in vivo performance of a formulation based it's in vitro profile, physicochemical properties of the molecule and the absorption, distribution, metabolism and excretion of the drug. Experts at PharmaServ strive to provide an educated opinion of in vivo performance of a product based on the information generated by you and their extensive experience in the field. Our Scientific Affairs services include the following:
- Formulation and Bioequivalence Evaluation
- Bioanalytical Methods Assessment
- Bioequivalence and Bioavailability Study Designs
- Preparation of Study Protocols
- Preparation of Study Reports
PharmaServ specializes in bioequivalence solutions for both generic and innovator products.
Whether you require a standard two way crossover study on fasting or fed conditions, a pharmacodynamic (PD) study on a biologic or skin irritation and sensitization study, we can take care of that for you.
Our experts have designed and performed hundreds of studies. We conduct your study from protocol design through the clinic, bioanalytical and pharmacokinetic and statistical groups. We provide you with a final report ready for regulatory submission. If desired, we can also provide any part of the whole process.
Selective and sensitive analytical methods for the quantitative evaluation of drugs and their metabolites are critical for the successful conduct of preclinical, biopharmaceutics and clinical pharmacology studies. Well-characterized and fully validated bioanalytical methods are essential for reliable results. These various essential development and validation characteristics for bioanalytical methodology have been discussed with view to improving the standard and acceptance in this area of research. Bioanalytical method validation includes all of the procedures that demonstrate that a particular method used for quantitative measurement of analytes in a given biological matrix, such as blood, plasma, serum, or urine, is reliable and reproducible for the intended use.
We provide assistance to sponsors of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements in developing bioanalytical method and validation information used in human clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies requiring pharmacokinetic (PK) evaluation.
| 
