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Are in vitro metabolism and drug-drug interaction studies critical for an investigational new drug application?

Drug Discovery World

In vitro ADME and drug-drug interaction (DDI) investigations are early activities in the drug development process that are critical for framing downstream decision making. Participants will gain insight into the specific needs and utility for in vitro ADME and DDI investigations in the drug development process.

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CDSCO releases draft guidance document on stability studies of IVD Medical Devices

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the import or manufacturing license applications.

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In Vitro Pharmacology Working Group to address data standards

Drug Discovery World

A new In Vitro Pharmacology Working Group to accelerate regulatory submissions has been created by the Pistoia Alliance, a global advocate for greater collaboration in life sciences R&D. The post In Vitro Pharmacology Working Group to address data standards appeared first on Drug Discovery World (DDW).

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New EU in vitro regulations delaying access to treatments

Drug Discovery World

The In Vitro Diagnostic Regulation (IVDR) came into effect in May 2022. The number of clinical trials delayed is expected to run into the hundreds, affecting up to 42,200 patients over the next three years, according to a survey run by EFPIA. However, this process is currently complex and uncoordinated.

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In vitro 3D-engineered heart tissue that monitors drug-induced cardiotoxicity

Medical Xpress

Recently, a joint team of researchers from POSTECH and Georgia Institute of Technology successfully created an engineered heart via 3D printing technology that allows for early monitoring of drug-induced cardiotoxicity. The left ventricle's contractile ability is impaired, potentially leading to heart failure, a severe clinical outcome.

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Women’s health company Obseva to wind down, lay off staff

Bio Pharma Dive

The company is still attempting to “monetize” its most advanced drug, a treatment to aid pregnancy via in vitro fertilization.

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Promising results from in vitro combination therapy against COVID-19

Scienmag

Researchers at Karolinska Institutet in Sweden report promising results from an in vitro combination therapy against COVID-19. Credit: Martin Stenmark.