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Testing Toxicity to Advance to Phase I Clinical Trials

Testing Toxicity to Advance to Phase I Clinical Trials

Preclinical research teams enter each drug testing project with the same hope – that the drug will meet all the safety requirements in order to advance to phase I clinical trials in humans.  In laboratory experiments, scientists will test their ideas for new...

Good Communication Essential To Successful Preclinical Testing

Good Communication Essential To Successful Preclinical Testing

For both large and small drug development companies, good communication displayed throughout the preclinical testing process is essential to success. Project leaders who exhibit great awareness, flexibility and communication skills can’t be undervalued in the timely...

PROTACs and Their Role in Catalyzing Health Solutions

PROTACs and Their Role in Catalyzing Health Solutions

PROTACs, otherwise known as PROteolysis TArgeting Chimera, emerged as a novel therapeutic modality in drug development and currently show promising clinical results for tackling some of the most complex diseases. PROTACs are designed to leverage the body’s internal...

An Important First Step in the Design of a Preclinical Program

An Important First Step in the Design of a Preclinical Program

In the design of a preclinical program, identifying and understanding the broad classification of the molecule is the priority. Is it a small molecule, a chemical, a manufactured drug? Or is it a biologic or a large molecule, a construct of amino acids, providing a...

ICH M10: Preview New Bioanalytical Method Validation Guidance

ICH M10: Preview New Bioanalytical Method Validation Guidance

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is in the process of revising M10, a multidisciplinary guideline that governs bioanalytical method validation. Drugs need to contain the correct...

Pathologists Can Move Your Drug Development Program Forward

Pathologists Can Move Your Drug Development Program Forward

Pathologists examine the causes and mechanisms of diseases and, in the world of drug development, that means collecting, processing and analyzing tissue for toxicity. Histotechnologists fix tissue samples onto slides, stain them to distinguish types of cells and cell...