FDA Issues Guidance on Clinical Pharmacology for Peptide Drugs
PharmaTech
DECEMBER 15, 2023
The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.
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Clinical Pharmacology by ClinicalKey
RX Note
APRIL 9, 2023
Introduction Clinical Pharmacology powered by ClinicalKey provides current, dependable drug information, including off-label indications, to guide treatment recommendations. Drug Class Overviews Provides information on therapeutic use, comparative efficacy, adverse reactions and drug interactions.
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ACMT Toxicology Visual Pearl: The Bark with Some Bite
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MARCH 5, 2024
European Journal of Clinical Pharmacology. European Journal of Clinical Pharmacology. British Journal of Haematology. 2017;177(5):674-683. PMID: 28106908. Schmid B, Kötter I, Heide L. Pharmacokinetics of salicin after oral administration of a standardised willow bark extract. 2001;57(5):387-391. PMID: 11599656.
Interview: CRO PPD of Thermo Fisher - the processes and difficulties within rare diseases
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NOVEMBER 17, 2023
OSP was delighted to speak to Galina Nesterova, executive medical director at the Rare Disease & Pediatrics Center of Excellence, and Susan McCune, vice president of pediatrics and clinical pharmacology both within medical science and strategy at PPD, part of Thermo Fisher.
Translating complex data into actionable insights, to create big value for smaller biotech companies
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FEBRUARY 20, 2024
Why clinical pharmacology is critical to accelerating drug development, and how it can help drive value in a complex and rapidly evolving landscape.
Greg Smith appointed New Director of U.S. FDA India office
Express Pharma
AUGUST 1, 2024
His career prior to joining the FDA includes significant roles in clinical research organisations, where he was instrumental in founding a Phase I clinical pharmacology centre and managed key projects in late-phase clinical trials, risk evaluation, post-marketing strategies, and surveillance initiatives.
Voquezna Dual Pak and Triple Pak From Phathom Pharmaceuticals, Inc
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DECEMBER 30, 2022
This month's clinical pharmacology update looks at a medication to manage Helicobacter pylori infection in adults.
Zydus begins Phase II trial of ZYIL1, NLRP3 inhibitor in patients with ALS
Express Pharma
OCTOBER 24, 2023
Zydus has established the Phase 2 proof-of-concept in CAPS patients [NCT05186051] and has now published the data in Clinical Pharmacology in Drug Development. In Phase I studies, ZYIL1 was found to be safe and well-tolerated [NCT04731324, NCT04972188].
New radiopharmaceutical laboratory opens in Germany
European Pharmaceutical Review
MARCH 6, 2024
The facility will also have capacity to conduct non-clinical pharmacology studies for detailed characterisation of its first-in-class development candidates, according to Ariceum.
From Healing to Harm: The Unintended Consequences of Polypharmacy in Seniors
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British Journal of Clinical Pharmacology, 67(6), 689–700. Retrieved from British Journal of Clinical Pharmacology Jyrkka, J., British Journal of Clinical Pharmacology, 74(4), 627–633. Retrieved from British Journal of Clinical Pharmacology Family Caregiver Alliance. A., & O’Mahony, M.
Altasciences concludes US laboratory facility expansion
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NOVEMBER 1, 2023
It provides data for TK, PK, and PD determinations for supporting preclinical as well as clinical studies. The post Altasciences concludes US laboratory facility expansion appeared first on Pharmaceutical Business review.
The challenge of handling highly potent API and ADCs in analytical chemistry
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JUNE 28, 2022
During the last decade demand for analytical chemistry on HPAPIs has grown rapidly, mainly due to advances in clinical pharmacology and oncology research. All dosage forms may utilise HPAPIs including parenteral and solid dosage forms.
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Hypersensitivity reactions to rifampin: Pathogenetic mechanisms, clinical manifestations, management strategies, and review of the anaphylactic-like reactions. Clinical pharmacology, therapeutic use and potential of COMT inhibitors in Parkinson’s disease. Medicine (Baltimore) 1999;78(6):361-9. PMID 10575418 Kaakkola S.
WHO INN approves ‘Usnoflast’ as recommended name for ZYIL1 from Zydus
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APRIL 1, 2024
Zydus was the first to establish the Phase 2 proof-of-concept in Cryopyrin-associated periodic syndromes (CAPS) patients [NCT05186051], and published the Phase 2 results in ‘Clinical Pharmacology in Drug Development’.
Allucent to expedite Covid-19 booster vaccines development
Pharmaceutical Business Review
AUGUST 28, 2023
Allucent is engaged in providing comprehensive drug development solutions including consulting, biometrics, clinical operations, and clinical pharmacology across various therapeutic areas. The post Allucent to expedite Covid-19 booster vaccines development appeared first on Pharmaceutical Business review.
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Zydus receives USFDA approval to initiate Phase II clinical trial of ZYIL1 for Parkinson’s disease
Express Pharma
DECEMBER 18, 2023
The phase-2 data of ZYIL1 in CAPS has now been published in “Clinical Pharmacology in Drug Development”. Previously, Zydus had demonstrated efficacy of ZYIL1 in CAPS (Cryopyrin Associated Periodic Syndrome) patients and was the first to establish the phase 2 proof of-concept with an oral small molecule NLRP3 inhibitor in CAPS patients.
Nausea and Vomiting
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APRIL 16, 2023
External Links Disease Management: A Guide to Clinical Pharmacology, 2016 Rang & Dale’s Pharmacology, 2019 Nonetheless, domperidone should be avoided in patients with conduction disorders or cardiac disease due to its association with Q-T interval prolongation.
Injection could help postpartum depression, says study
European Pharmaceutical Review
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BRII-296 is a new gamma-aminobutyric acid A (GABAa) receptor positive allosteric modulator (PAM), a type of benzodiazepine medication that regulates the nervous system by easing brain activity.
Lipid Nanoparticles Immunogenicity & Toxicity | December 6-8, 2022
pharmaphorum
AUGUST 16, 2022
The highly anticipated Lipid Nanoparticle Immunogenicity & Toxicity Summit takes place this December to unite 80+ senior leaders as the definitive meeting for clinical pharmacology , immunogenicity , bioanalytical development leaders to stay at the forefront, arming you with practical takeaways and lessons learned.
Syneos Health appoints Michael Brooks as Chief Development Officer
pharmaphorum
JULY 23, 2021
Prior to Syneos Health, he was president & global head of LabCorp’s (Covance) clinical development & commercialisation services where he was responsible for phase I-IV services, FSPx services, clinical pharmacology/phase I units, global service delivery hubs in China and India, and commercial services.
Zydus gets Orphan Drug Designation from USFDA for ZYIL1 to treat Cryopyrin Associated Periodic Syndrome
Express Pharma
MARCH 21, 2023
In September 2022, Zydus had announced positive Phase 2 proof-of-concept (POC) study in CAPS patients, and the publication of Phase 1 study results in Clinical Pharmacology in Drug Development, supporting the advancement of ZYIL1 into pivotal clinical trials in CAPS patients.
9th PREDiCT: Tumor Models Cell Therapy Summit
pharmaphorum
APRIL 6, 2021
Here’s a quick look at our world-class speaker faculty: Ganesh Mugundu , Head of Cell Therapy Clinical Pharmacology & Modelling, Takeda. Shiva Kazerounian , Associate Director & Principal Scientist – In Vivo Pharmacology, Berg Health. Boris Engels , Associate Director, Novartis.
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Genetic screening before prescribing could benefit millions, study finds
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JANUARY 29, 2021
This would have reduced their risk of side effects and could have led to better clinical outcomes.”. emptive pharmacogenetic testing in primary care across the UK’ is published in the British Journal of Clinical Pharmacology. Estimating the potential impact of implementing pre?emptive
AbbVie extends Gedeon Richter alliance that gave it Vraylar
pharmaphorum
MARCH 11, 2022
AbbVie’s chief scientific officer Tom Hudson said the aim of the new alliance with Gedeon Richter will be to “provide additional insights into our understanding of cariprazine’s clinical pharmacology and explore novel chemistry to identify new dopamine receptor modulators.”
14th Annual RNA Therapeutics Conference
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NOVEMBER 1, 2022
Director, Clinical Pharmacology. Clinical Science Director. Chief Medical Officers. Chief Technical Officers. Senior Vice Presidents. Global Heads of mRNA R&D. Global Medical Directors. Heads of Translational Medicine. Global Head of RNA and Targeted Therapeutics. Head of Biology. Director, Genetic Medicine.
Case Study 4 – Successful US/EU Marketing Applications for Big Pharma
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AUGUST 9, 2022
This work included authoring 9 CSRs (8 Phase 3 and 1 Phase 2b) as well as the Integrated Summaries of Efficacy and Safety (ISE and ISS), Summaries of Clinical Efficacy and Safety (Modules 2.7.3 and 2.7.4), Summaries of Biopharmaceutic Studies and Clinical Pharmacology (Modules 2.7.1
New Initiative of the US FDA: The Role of Pharmacodynamic Biomarkers for the Development of Biosimilar
PharmaShots
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A recent study published in the January 2023 issue of Clinical Pharmacology and Therapeutics described essential characteristics of a PD biomarker for biosimilar development.
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At Long Last, FDA Unveils Plan for Rare Disease Innovation Hub
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clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g., In fact, at this Scientific Workshop, Frank called for the creation of an alternative effectiveness standard for ultra rare diseases that relies on all available scientifically valid evidence (e.g.,
Episode 782: Wernicke’s Encephalopathy Treatment During an IV Thiamine Shortage
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However, a study published in 2012 in BMC Clinical Pharmacology challenges that concept and seems to show that at very high doses there must be some form of passive, non-saturable absorption of thiamine. Healthy subjects were given oral thiamine at doses of 100 mg, 500 mg, and 1500 mg.
Lilly adds to pain pipeline with Asahi Kasei licensing deal
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Episode 782: Wernicke’s Encephalopathy Treatment During an IV Thiamine Shortage
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However, a study published in 2012 in BMC Clinical Pharmacology challenges that concept and seems to show that at very high doses there must be some form of passive, non-saturable absorption of thiamine. Healthy subjects were given oral thiamine at doses of 100 mg, 500 mg, and 1500 mg.
AdComms – Is FDA Getting Less Advice?
Eye on FDA
AUGUST 4, 2021
The most active of these committees with vacancies this year has been the Oncologic Drugs Advisory Committee. Also the vacancies on the Peripheral and Central Nervous System Drugs Advisory Committee largely reflect the protest of the FDA approval decision in Alzheimer’s.
FDA Advisory Committee Review of 2021
Eye on FDA
JANUARY 5, 2022
Here is where FDA currently has vacancies: Bone, Reproductive and Urologic Drugs Advisory Committee – 4 vacancies Gastrointestinal Drugs Advisory Committee – 1 vacancy Pharmaceutical Science and Clinical Pharmacology Advisory Committee – 4 vacancies Pharmaceutical Compounding Advisory Committee – 1 vacancy.
Episode 573: Ceiling dose of ketorolac for renal colic in the ED
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In 1989, a study in the Journal of Clinical Pharmacology compared 10, 30, and 90 mg of IM ketorolac with placebo in 126 patients with cancer pain. While all doses were more effective than placebo, there was no difference in effectiveness between 10, 30, or 90 mg of IM ketorolac.
2022 in review: Drug development milestones for tropical diseases
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This year saw great progress towards making new therapeutics for malaria available sooner rather than later, says Karen Barnes, PhD, professor at the University of Cape Town’s Division of Clinical Pharmacology.
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FDA Guidance Outlines a Framework for the Evaluation of Long-Term Neurodevelopmental Safety Studies in Neonatal Product Development
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OCTOBER 28, 2024
The Guidance notes that extrapolation of data across species is challenging; however, in accord with Agency pronouncements elsewhere on this topic, the Guidance describes FDA’s limited experience with alternative assays to characterize neurodevelopmental toxicity while expressing a theoretical openness to such methods when feasible.
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Adverse Drug Reaction Drug Induced Diseases, 2018 Meyler's Side Effects of Drugs, 2015 Antibiotics The Sanford Guide to Antimicrobial Therapy, 2022 Breastfeeding Briggs' Drugs in Pregnancy and Lactation, 2021 Hale's Medications and Mothers' Milk, 2021 Clinical Practice Applied Therapeutics, 2018 Conn’s Current Therapy, 2022 Current Medical Diagnosis (..)
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FDA Releases Draft Labeling Guidance for Biosimilar Products
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SEPTEMBER 25, 2023
With respect to immunogenicity data, the 2023 Draft Guidance suggests that a contextual paragraph generally be included in the relevant CLINICAL PHARMACOLOGY subsection before describing the available immunogenicity data for the reference product and the biosimilar or interchangeable biosimilar product.
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Developing new treatment regimens for HIV
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MARCH 11, 2024
With therapeutic expertise in HIV, hepatology and rare diseases, Sherene has additional expertise in clinical pharmacology and drug safety. Prior to joining ViiV, she served at an industry position with Roivant Sciences as Vice President of Clinical Research, where she managed the Rare Diseases portfolio.
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7 Petra Doerr, Marie Valentin, Nobumasa Nakashima, Nick Orphanos, Gustavo Santos, Georgios Balkamos & Agnes Saint-Raymond (2021) Reliance: a smarter way of regulating medical products – The IPRP survey, Expert Review of Clinical Pharmacology, 14:2, 173-177. Published 2021 Apr 9. Regulatory science strategy.
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He received an MD from the Georg August University of Göttingen and completed a postdoctoral Master’s in Medical Sciences Clinical Pharmacology at the University of Glasgow. Dr Mieke Borgs has been Head of Clinical Operations Europe at BeiGene since May 2020.
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