Drug Discovery World

JULY 25, 2023

Furthermore, the guideline discusses the data requirements to support paediatric clinical investigations for both drugs and devices as well as the procedures needed for sedation in paediatric clinical investigations. This approach, together with very sparse, confirmatory PK data, for example, is discussed by Small et al.

Drug Development 130

Drug Development Clinical Pharmacology Pharmacokinetics Drugs 130

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. Pitceathly argued that interdisciplinary collaboration and good preclinical data is key to successful clinical trials.

Clinical Pharmacology 100

Clinical Pharmacology Clinical Trials Drugs Trials 100

New Drug Approvals

DECEMBER 24, 2023

2] [3] [4] [5] It was approved for medical use in the United States in December 2023. [6] 7 March 2023. Archived from the original on 26 September 2023. Retrieved 21 December 2023 – via PR Newswire. February 2023). October 2023). 21 December 2023. 22 December 2023. Ionis Pharmaceuticals.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology Pharmacokinetics 62

Alta Sciences

OCTOBER 30, 2023

Top 10 Life Science Resources pmjackson Mon, 10/30/2023 - 16:16 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below! Read or listen now. Watch it now.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

Agency IQ

JULY 28, 2023

This proposal is an exciting example of how new approaches at the forefront of clinical pharmacology can be leveraged to address the problems being discussed in other forums (e.g., AgencyIQ walks through the new projects below. Read the full AgencyIQ analysis here.

FDA 40

FDA Pharmacokinetics Clinical Pharmacology Government 40

Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The committee also made recommendations regarding pharmacokinetic and safety assessments.

Science 40

Science FDA Clinical Trials Pharmacy 40

Agency IQ

DECEMBER 1, 2023

BY RACHEL COE, MSC | NOV 27, 2023 8:24 PM CST FDA’s transition away from public health emergency (PHE)-related guidance documents The Covid-19 Public Health Emergency (PHE) was activated on January 31, 2020. In January 2023, the White House announced that the federal Covid-19 national emergency and PHE would officially end on May 11, 2023.

FDA 40

FDA Clinical Trials Vaccine Trials 40