Drug sponsors looking to initiate clinical trials for new products must first secure approval from regulators. This authorization can only be granted following an Investigational New Drug (IND) submission, and the entire development process is on hold until approval is granted.
A successful Investigational New Drug (IND) submission requires a comprehensive testing approach. From Drug Metabolism and Pharmacokinetic (DMPK) studies to determine the drug’s behavior within the body, nonclinical toxicology assessments to meticulously examine its safety profile, and Bioanalytical studies to measure drug concentrations in biological samples, the process plays a critical role in drug development.
Investigational New Drug (IND) studies play an essential role in the drug development journey. This testing helps researchers foresee safety concerns and estimate the most efficacious starting doses for clinical trials.
A successful Investigational New Drug (IND) application is imperative for research involving human participants ingesting or applying a drug product. Sponsors can take several potential regulatory pathways, but all pose unique challenges and requirements. The right laboratory testing partner can ease this process, avoiding longer timelines and bloated budgets. Drug sponsors should consider these three key areas before selecting a lab partner.
Oligonucleotides (oligos), including small interference RNAs (siRNAs) and antisense oligonucleotides (ASOs), represent a novel class of therapeutic agents capable of precisely targeting and regulating gene expression. This precision allows the potential treatment of various diseases, from genetic disorders to cancers, by silencing harmful genes or correcting genetic abnormalities.
Oligonucleotide drugs have become a hot topic in biomedicine due to their strong specificity, well-established design strategy, short development cycle, and wide range of targets.
In vitro ADME assays provide the data necessary to ensure the safety and efficacy of your drug candidates. Automating these tests can shorten the time it takes your product to reach the market.
In the evolving landscape of drug development, oligonucleotide drugs (ONDs) stand at the forefront of innovative therapeutic solutions. As the pharmaceutical industry shifts towards addressing complex genetic disorders and resistant forms of cancer, ONDs offer a promising avenue due to their ability to precisely target and modulate gene expression.
Safety assessment studies are critical to the progression of your drug candidate through the preclinical and clinical development process. In this blog, we cover six types of studies that you might need to include.
Learn why testing drug solubility is important across the drug discovery and development continuum.
Learn why testing drug solubility is important across the drug discovery and development continuum.
Learn why testing drug solubility is important across the drug discovery and development continuum.