2014 and Clinical Pharmacology - Drug Discovery Digest

What recent paediatric guidelines mean for drug developers

Drug Discovery World

JULY 25, 2023

General clinical pharmacology This FDA draft guidance was previously issued in 2014 but was re-issued for comments again in 2022. The guidance covers three main areas: clinical pharmacology considerations, ethical considerations, and the paediatric study plan design including points to consider.

Drug Development

Drug Development Clinical Pharmacology Pharmacokinetics Drugs

Drug repurposing: The benefits, risks and what we learned from Covid-19

Drug Discovery World

JULY 20, 2023

Diana Spencer summarises the key messages from the ‘Drug Repurposing: Challenges and Opportunities’ Symposium held at the 19th World Congress of Basic & Clinical Pharmacology (WCP) 2023.

Clinical Pharmacology

Clinical Pharmacology Clinical Trials Drugs Trials

Webinar: Assessing Cognition Impairment Using Driving Simulators in Clinical Trials

Alta Sciences

FEBRUARY 8, 2024

Utilizing 10 state-of-the-art simulators available in-house at our Montréal clinical facility (with the capacity for more than 20), we are equipped to measure a range of studies; from impairment in cognition and comparing compounds to assessing the impact on new formulations have on impairment.

Clinical Trials

Clinical Trials Trials Clinical Pharmacology Clinical Development

Mission Therapeutics Appoints Dr Suhail Nurbhai as Chief Medical Officer

The Pharma Data

NOVEMBER 1, 2020

Dr Nurbhai has more than 25 years of experience and a strong track record in the strategic and operational leadership of all phases of clinical research and development at companies across Europe and the US. He joins Mission from VHsquared, where he held the position of CMO since 2014.

Clinical Pharmacology

Clinical Pharmacology Small Molecule Clinical Research Science

Re-assessing the risks of drug-induced arrhythmias during drug discovery

Drug Discovery World

AUGUST 15, 2023

The pre-clinical pharmacological effects observed in such experimental model systems need to translate meaningfully into human clinical data to guide effective decision making in drug discovery. Journal of Cardiovascular Pharmacology, 20: S96-105 Aktas et al. Clinical Pharmacology & Therapeutics.

Drugs

Drugs Clinical Pharmacology Disease Engineering

Metabolism of macrocyclic drugs

Metabolite Tales Blog

JULY 5, 2023

20 (March 20, 2014). link] [6] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION Study NC219 [link] [7] Acute Liver Injury due to Glecaprevir/Pibrentasvir in a Patient with Chronic Hepatitis C Virus Infection without Cirrhosis. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION.

Metabolic Stability

Metabolic Stability Drugs FDA Approval Treatment

Metabolism of de novo designed macrocyclic drugs

Metabolite Tales Blog

JULY 5, 2023

20 (March 20, 2014). link] [6] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION Study NC219 [link] [7] Acute Liver Injury due to Glecaprevir/Pibrentasvir in a Patient with Chronic Hepatitis C Virus Infection without Cirrhosis. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION.

Metabolic Stability

Metabolic Stability Drugs FDA Approval Treatment

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

As part of the classification process, we are required to discuss the potential classification before an advisory committee and seek the committee’s recommendation on classification, which took place in October 2014.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

As part of the classification process, we are required to discuss the potential classification before an advisory committee and seek the committee’s recommendation on classification, which took place in October 2014.

Regulations

Regulations FDA Science Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

As part of the classification process, we are required to discuss the potential classification before an advisory committee and seek the committee’s recommendation on classification, which took place in October 2014.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

As part of the classification process, we are required to discuss the potential classification before an advisory committee and seek the committee’s recommendation on classification, which took place in October 2014.

FDA

FDA Science Regulations Production

Drug Discovery Digest

What recent paediatric guidelines mean for drug developers

Drug repurposing: The benefits, risks and what we learned from Covid-19

Trending Sources

Webinar: Assessing Cognition Impairment Using Driving Simulators in Clinical Trials

Mission Therapeutics Appoints Dr Suhail Nurbhai as Chief Medical Officer

Re-assessing the risks of drug-induced arrhythmias during drug discovery

Metabolism of macrocyclic drugs

Metabolism of de novo designed macrocyclic drugs

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

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