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About SB Drug Discovery SB Drug Discovery is an industry leader in specialist contract research, providing critical data for novel drug development through cell line generation, assaydevelopment and compound screening services. SB is based in Glasgow and employs 55 people.
With the depth of knowledge to support all types of pharmaceutical products across all phases of development, we provide services ranging from end-to-end assaydevelopment to platform expansion, designed with the client’s timeline and budget in mind. Stay ahead of the curve with a great GMP/CMC contract laboratory partner.
In drug development, assays are test systems that gauge the effects of chemical compounds on certain cellular, molecular, or biochemical processes. They are a vital step in modern pharma research that pushes drugs to market faster. These are just three of the steps to take toward reliable and replicable assaydevelopment.
TIB Molbiol excels in ultra-rapid assaydevelopment for emerging infectious disease, strongly demonstrated during the COVID-19 pandemic. The acquisition enables Roche to further expand the portfolio of currently over 45 CE-IVD assays and more than 100 research use assays on Roche`s LightCycler PCR instruments. “We
This comprehensive toolbox of Type 1, Type 2, Type 3 and Type 4 anti-idiotypic antibodies provides PK and ADA assaydevelopers with enhanced flexibility for a thorough analysis of antibody candidates. Prior to this, he worked at an in vitro immuno-diagnostic company as Strategic Marketing Manager. Adapted from Harth S et al. (8)
In May 2022, FDA responded to industry interest with a draft guidance on the use of ctDNA as a biomarker in investigational new drug (IND) and marketing applications for products intended to treat solid tumor malignancies in the early-stage setting. Read AgencyIQ’s analysis of the white paper and the meeting at which it was discussed here. ]
The protocol and statistical analysis plan should clearly specify the plans for specimen collection, sample analysis and related clinical outcomes depending on the biomarker assaydevelopment and validation strategy. Umbrella trials investigate multiple drugs or drug combinations in one disease. randomized control arms) are met.
Similarly, the EMAs PRIority MEdicine (PRIME) designation and conditional marketing authorization enable accelerated approval for drugs addressing critical and underserved medical needs, provided they meet stringent evidence requirements.
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