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The Wizard of Oligos: There’s no place like having a successful drug development program!

Oligonucleotide therapies— nucleic acid polymers with the potential to treat or manage a wide range of diseases— are experiencing tremendous growth in the pharmaceutical industry. But, performing the needed PK/PD and clinical pharmacology assessments to optimize the safety and efficacy of investigational oligonucleotide candidates and gain regulatory approval can be challenging. It’s enough to make … Continued

第 4 部分:Best Practices for oligonucleotide therapeutic development: Q&A

In the last few years, the pharmaceutical industry has invested in developing Complex Biologics including proteins, oligonucleotides, viral vectors, and engineered cells. One area within Complex Biologics experiencing tremendous growth is oligonucleotide therapies— nucleic acid polymers with the potential to treat or manage a wide range of diseases. Certara supported the first FDA approval of … Continued

第 3 部分:Oligonucleotide therapeutic development: Clinical pharmacology considerations

In the last few years, the pharmaceutical industry has invested in developing Complex Biologics including proteins, oligonucleotides, viral vectors, and engineered cells. One area within Complex Biologics experiencing tremendous growth is oligonucleotide therapies— nucleic acid polymers with the potential to treat or manage a wide range of diseases. Certara supported the first FDA approval of … Continued

第 2 部分:Oligonucleotide therapeutic development: Pre-clinical and translational considerations

In the last few years, the pharmaceutical industry has invested in developing Complex Biologics including proteins, oligonucleotides, viral vectors, and engineered cells. One area within Complex Biologics experiencing tremendous growth is oligonucleotide therapies— nucleic acid polymers with the potential to treat or manage a wide range of diseases. Certara supported the first FDA approval of … Continued

第 1 部分:What are oligonucleotide therapeutics, and how do they work?

In the last few years, the pharmaceutical industry has invested in developing Complex Biologics including proteins, oligonucleotides, viral vectors, and engineered cells. One area within Complex Biologics experiencing tremendous growth is oligonucleotide therapies— nucleic acid polymers with the potential to treat or manage a wide range of diseases. Certara supported the first FDA approval of … Continued

Predicting the Effect of the Dulaglutide-Mediated Gastric Emptying Delay on Drug Exposure

The European Medicines Agency (EMA) recently approved dulaglutide (Trulicity®) at higher doses (3 mg and 4 mg solutions).  Dulaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.  Dulaglutide delays gastric emptying and has the potential to impact the rate of absorption of … Continued

Modelling and simulation facilitates drug repurposing to counter Covid-19

By Dr Craig R. Rayner, FRCP Edin, PharmD, MBA, President, Integrated Drug Development at Certara Right at the start of the Covid-19 pandemic, medical researchers began questioning whether there were any existing, on-market drugs that might prove effective against SARS-CoV-2. They wanted to offer healthcare professionals and patients some known therapeutic options while researchers quickly began developing … Continued

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