Drug Discovery Services
DRUG DISCOVERY SERVICES
The creation of a pharmaceutical is an incredibly complex process that involves multiple rounds of assays and tests. It is a highly cost intensive and time consuming process.
We understand that the potential to reduce the time of the drug trials is very limited, due to the nature of studies and regulatory guidelines. However we significantly reduce the cost of discovery by early elimination of inappropriate IND before the preclinical trials by designing a stringent in vitro screening program.
We extend our services to support the drug discovery process in three stages.
Elucidation of Structure and Other Characteristics of the drug substance and Reference Standards or Materials
The process of drug discovery begins with designing a novel molecule, synthesizing it and filing for Type-II drug master files (DMFs) (1) are submissions of drug substance information to FDA for obtaining the regulatory approvals.
A DMF must be adequate for referenced Investigational New Drug Application (IND), a New Drug Application (NDA), and an Abbreviated New Drug Application (ANDA) to be approved.
To establish the drug substance identity or in-house reference standards, we provide the researchers a comprehensive structural elucidation information, including studies based on
- Infrared (IR) spectroscopy
- Nuclear magnetic resonance (NMR) spectroscopy
- Ultraviolet (UV) spectroscopy
- Mass spectrometry (MS)
- Elemental analysis (EA)
- Powder X-ray diffraction
- Differential scanning calorimetry (DSC)
- Specific optical rotation, where applicable.
In Vitro Studies in Drug Discovery and Development
In vitro pharmacology is one of the key methods that researchers use to generate high- quality information on the safety and efficacy of their drug candidates and more.
The purpose of in vitro studies to extensively optimize the biological activity and properties of the leads. The second important objective is to eliminate molecules that are not delivering results in desired range, thereby saving cost by preventing entry of such molecules in preclinical trials.
It has been estimated that on an average, only one in 5,000 compounds that enter pre- clinical trials becomes an approved drug. So in vitro studies need to be planned and executed to the highest standard and stringency.
We have optimized following In-vitro Cell bases assays in our lab
- Cell Viability Assays
- Cell Proliferation Assays
- Cytotoxicity Assays
- Cell Senescence Assays
- Cell Death Assays (Apoptosis, Autophagy and Necrosis)
Preclinical (Animal Studies) and In Vitro Pharmacology in Pre-Clinical Trials
When a drug candidate enters the pre-clinical trials phase, researchers already know it is effective against a certain disease or infection. However, there is not yet enough information about this chemical’s safety, toxicity, pharmacokinetics, and metabolism in humans, which is obtained through animal studies.
U.S. Food and Drug Administration requires that before a drug is tested on humans, the manufacturer submits a body of pre-clinical data on safety, typically obtained through in vitro and in vivo studies. So we have built our capabilities around both the verticals to provide an extended support to scientists.
Safety pharmacology is a crucial stage of the pre-clinical development process. Its purpose is to assess any potential undesirable effects of the drug on the body’s major systems. Although in the past, the majority of safety testing of pharmaceuticals was conducted on animals, today, safety tests are increasingly made using in vitro models that involve isolated cell lines and tissues.
At the pre-clinical trial stage, we provide access to animal studies through our collaborators in a GLP set up and also provide the following in vitro pharmacology services to our researchers:
- Obtain high-quality data on the safety and toxicity of your drug candidate;
- Identify potential adverse effects early in the drug development process;
- Profile compounds to guide pre-clinical in vivo safety and toxicity studies;
- Assess the potency and efficacy of your drug candidate against the targeted disease;
- Gather data on pharmacokinetics and pharmacodynamics;
- Study the drug candidate’s mechanism of action in more depth; and
- Evaluate the activity of biosimilar compounds.
For More Enquires contact us.
Frequently Asked Questions
Yes, we can perform flow cytometry analyses using up to 8 colors.
Yes, please connect with us via E-mail on inquiry@niravbiosolutions.com for more information.
Please contact us using the WhatsApp feature available at our website or Email on inquiry@niravbiosolutions.com or call us at 8380036211 for further information.
Please contact us using the WhatsApp feature available at our website
OR
Call us at 8380036211 for further information
Yes, please connect with us via E-mail on inquiry@niravbiosolutions.com for more information.
All of the above listed services. For any other research services, Please contact us using the WhatsApp feature available at our website or Email on inquiry@niravbiosolutions.com or call us at 8380036211 for further information
Yes, Please contact us using the WhatsApp feature available at our website
OR
Email on inquiry@niravbiosolutions.com
OR
Call us at 8380036211 for further information.
Please connect with us via Email: inquiry@niravbiosolutions.com.