DrugBank

FEBRUARY 9, 2023

1 Present address: Functional Genomics and Metabolism Research Unit, Department of Biochemistry and Molecular Biology, University of Southern Denmark, Denmark. DrugBank Powered Research: Pharmacological knowledge about drug targets was analyzed based on a query of DrugBank. 2 Cancer Program, Broad Institute of MIT and Harvard, USA.

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Alta Sciences

JULY 25, 2024

Watch the poster presentation. TOP MANUFACTURING AND ANALYTICAL SCIENTIFIC RESOURCES Podcast: Successful Manufacturing of Clinical Trial Supply Join our formulation and pharmacy experts as they share insider secrets for overcoming clinical trial challenges and resolving issues that could impact your drug development program's timeline.

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The Premier Consulting Blog

NOVEMBER 4, 2023

If an excipient is not listed in the IID or is present in levels exceeding the IID, justification of the use level is required and may involve non-clinical subject matter experts. If the drug product is part of a drug-device combination, considerations for the drug component of the combination will be the same as those presented above.

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Alta Sciences

OCTOBER 30, 2023

Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drug development comes with its own set of clinical development requirements. Watch the video.

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Agency IQ

SEPTEMBER 15, 2023

According to the FDA’s agenda, linked above, and the meeting minutes , Leslie Hendeles, Randy Hatton, and Jonathan Shuster of the University of Florida gave presentations supporting the assertions they had made in their petition. CHPA supplemented the FDA’s presentation on retail volume with survey results on consumer preferences.

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Metabolite Tales Blog

JULY 5, 2023

Figure 1 Metabolism of simeprevir Glecaprevir (ABT493/A-1282576) is another antiviral drug for the treatment of chronic hepatitis C which also undergoes limited CYP3A4/5 mediated metabolism in vitro , and for which all human metabolites were present in at least one animal species. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION.

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Metabolite Tales Blog

JULY 5, 2023

Figure 1 Metabolism of simeprevir Glecaprevir (ABT493/A-1282576) is another antiviral drug for the treatment of chronic hepatitis C which also undergoes limited CYP3A4/5 mediated metabolism in vitro , and for which all human metabolites were present in at least one animal species. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION.

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Agency IQ

FEBRUARY 23, 2024

In between, panelists and presenters also discussed alternative designs for dose-finding trials and creative strategies for evaluating and modeling early clinical data. I’m not going to say which one is better,” said JIANG LIU, scientific lead at the FDA’s Division of Pharmacometrics in the Office of Clinical Pharmacology.

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Agency IQ

JULY 8, 2024

Start Date End Date Event Event Type Center 07/10/2024 07/10/2024 Medical Device Sterilization Town Hall: Mock Pre-Submission on Implementing a Change in Sterilization Method Webcast CDRH 07/10/2024 07/10/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Exploring Religious Literacy and Spirituality in Cancer Care” Webcast (..)

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Agency IQ

OCTOBER 20, 2023

Biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinical pharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability. Developing biosimilars is an extensive and expensive process.

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Agency IQ

DECEMBER 11, 2023

OCE leadership and staff also kept AgencyIQ staff very busy in 2023 as they attended and presented at countless meetings. months, according to the GSK presentation. To start, age was repeatedly mentioned by OCE presenters at meetings in 2023 and was featured in several guidance documents published by OCE as well.

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Agency IQ

OCTOBER 27, 2023

Government shutdown: At present, the U.S. Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. Expect nearly every company to be closely reading this document when it’s eventually published.

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Agency IQ

JUNE 16, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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Agency IQ

JUNE 2, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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The Pharma Data

MARCH 8, 2022

Dr. Gunther Hartmann from the Institute of Clinical Chemistry and Clinical Pharmacology at the University Hospital Bonn, in cooperation with other members of the cluster of excellence ImmunoSensation2 at the University of Bonn, have shown this in mice. Researchers led by Prof. Mouse model to resemble human COVID-19 infection.

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Alta Sciences

JULY 31, 2024

Dr. David Nguyen , General Manager and Medical Director of Altasciences’ Los Angeles clinical pharmacology unit, says: “Having a diverse medical team working with a diverse participant population can lead to a rewarding experience for both.

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Agency IQ

JULY 28, 2023

According to the notice, the contract includes at least three deliverables: (1) an internal report or presentation to FDA, (2) a public workshop with stakeholders using data collected and published in the Federal Register Notice, and (3) a summary of the public workshop and recommendations to inform potential updates to FDA’s guidances.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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The Anticancer Fund

JUNE 7, 2022

Please get in touch if you’re interested in discussing research based on the findings presented below ( info@anticancerfund.org ). All articles need to be critically assessed and viewed in their broader research context.

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Agency IQ

FEBRUARY 15, 2024

FDORA Legislation Antimicrobial FDA will publish a draft guidance describing considerations for developing presentations, container closure systems and device constituent parts for proposed interchangeable biosimilar biological products.

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The Pharma Data

FEBRUARY 8, 2021

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA ® (abiraterone acetate) CombinationS. Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month.

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Agency IQ

SEPTEMBER 29, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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Agency IQ

FEBRUARY 2, 2024

Government shutdown: At present, the FDA has appropriated funding March 1. QMSR final rule : For years, the FDA has been talking about harmonizing its Quality System Regulation with ISO 13485:2016, which it would incorporate by reference. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

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Agency IQ

DECEMBER 1, 2023

Government shutdown: At present, the FDA has appropriated funding through January 19. Both sections 503A and 503B provide that a compounded drug is not eligible for those exemptions if it is identified by FDA as presenting demonstrable difficulties for compounding. FDA finalized a ban on these devices in 2020, but the D.C.

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Agency IQ

MARCH 1, 2024

Government shutdown: At present, the FDA has appropriated funding lasting until midnight on Friday, March 1. Given that the rule is currently under White House review, we’re expecting this to soon be released. Note: If a link no longer works, it is likely because OIRA has since cleared the document.) and the E.C.

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FDA Law Blog: Drug Discovery

OCTOBER 28, 2024

raw scores, standardized norm-referenced scores), some of which might present floor or ceiling effects; and ensuring that selected COAs have demonstrated reliability across demographic groups. When a comprehensive neurodevelopmental evaluation is needed, it should include an evaluation of physical, mental, and social health.

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Drug Target Review

NOVEMBER 27, 2024

Finally, its application in urine samples presents additional challenges compared to serum. Clinical Pharmacology & Therapeutics. Outsourcing Biomarkers in Clinical Trials: Advantages and Disadvantages. Available from: [link] Bakker E, Hendrikse NM, Ehmann F, et al. 2022 Mar 5;112(1):69–80. 174-177.

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Agency IQ

JULY 12, 2024

Fall 2023 July 2024 Final Rule Amendment to Establishment Registration and Device Listing Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated as Devices Fall 2022 July 2024 Final Rule Prior Notice: Adding Requirement to Submit Mail Tracking Number for Articles of Food Arriving by International Mail (..)

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