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News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
It will be interesting to see what dosage form these data prompt the future development of. It also introduces a question on how to optimize the PK/pharmacodynamic profile for protein degraders, such as cereblon E3 ligase modulatory drugs and proteolysis-targeting chimeras, which are a burgeoning area of therapeutic development.”
Misconceptions about biosimilars include doubts about their safety, efficacy, and risks associated with switching from reference biologics. Biosimilars extend beyond cost savings, improving access to essential treatments, especially in underserved populations. 2 Misconceptions About BiosimilarsBiosimilars are the same as generics.
The study's primary objective was to assess reversion rates to Humira, with 9% reverting after three months, while 91% remained on biosimilars or switched to alternatives. SHOW MORE Real-world data shows patients switching from Humira to biosimilars Hadlima and Hyrimoz achieve similar outcomes without hospitalization.
Animal studies reveal dose-dependent hepatic responses to CBD, supporting the need for cautious monitoring even at consumer-relevant dosages. Pharmacists should review patient medication profiles, advise on appropriate dosage adjustments, and monitor for cumulative toxicity. of healthy adults, necessitating liver function monitoring.
Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. In the 505(j) ANDA approval pathway, on the other hand, submissions can be multisource generic drugs; however, this pathway requires bioequivalence to the RLD.
link] Seasonal influenza vaccine dosage & administration. September 17, 2024. Accessed May 29, 2025. link] RSV vaccine guidance for older adults. August 30, 2024. Accessed May 29, 2025. October 16, 2024. Accessed May 29, 2025. link] US FDA approves BLA for Novavax’s COVID-19 vaccine. News release. May 19, 2025. Accessed May 29, 2025.
2 Guiding prescribers and patients through initiation of lumatperone, adjusting dosage amounts, and switching from other antipsychotics, emphasizing its favorable relapse reduction profile is key in preventing relapse.
HME in drug manufacturing typically employs corotated twin extruders and uses heat and pressure to create solid dosage forms, dispersing the active pharmaceutical ingredient within a molten polymer matrix, and forming a solid solution or amorphous solid dispersion. It has been used frequently for manufacturing poorly soluble compounds.
By incorporating a patient's genetic profile into therapeutic decision-making, pharmacists can identify optimal drug choices and dosages while minimizing the risk of adverse events (AEs). Developed in partnership with InterSystems, the platform uses proprietary algorithms to personalize drug selection and dosage.
A group of experts will present an encore abstract titled " Prevalence of Dosage Modifications and Impact on Response Milestone Among Patients With CML Treated With Imatinib Using Real-World Data " at the 2025 Oncology Pharmacists Connect (OPC) meeting in Austin, Texas, from June 19 to 20.
They have a team of highly skilled distribution professionals who can juggle efficacy and safety checks along with compounding as if they were conductors of a world-class symphony. We need people to coordinate and track prior authorizations, write persuasive appeal letters, and keep patients updated.
Despite observational evidence, causation is not established, necessitating further research on dosage effects and neurocognitive outcomes. The inconsistency underscores the need for further research, particularly prospective studies that control for dosage and assess neurocognitive outcomes over time.
1 "[Meloxicam injection] demonstrates our commitment to improving patient care by providing an alternate dosage form for pain management," Ron Scarboro, chief executive officer at Azurity Pharmaceuticals, said in a press release. December 21, 2004. Subscribe Now!
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Limitations included open-label design and dosage constraints, but the multicountry approach enhanced generalizability and external validity. All patients underwent a 20-week correction period for dosage titration and Hb correction, which was followed by an 8-week evaluation for efficacy assessments. 1 REFERENCES 1.
In addition, the dosage [of 2000 IU per day] used in the research is far below the target dose for correcting vitamin D deficiency, which is usually 50,000 IU per week,” Carvalho-Pessoa said in a news release. 1,2 “Even with a small sample of participants, it was possible to observe a significant difference in the response to chemotherapy.
Selection of an appropriate OTC analgesic should take into consideration various patient factors, including the patient’s overall health status, current medical conditions, and medication profile, as well as patient preferences, which are often influenced by dosage form, required dosing intervals, and cost of OTC medication.
The biosimilar demonstrated comparable efficacy and safety to Stelara in a phase 3 clinical trial, supporting its FDA approval. Steqeyma provides a new dosage form and strength, enhancing treatment flexibility for young patients with chronic inflammatory conditions. The biosimilar is a 45 mg/0.5
2,3 LIMBER is a phase 1, open-label, dose escalation study evaluating INCB057643 as a monotherapy at a dose escalation of 4 to 12 mg daily (part 1) or in combination with ruxolitinib at a dosage of 4 mg once daily and escalating to the maximum tolerated dose in part 1 (part 2).
The investigators assessed a total of 90 patients who received talquetamab at a dosage of 0.8 mg/kg once every 2 weeks plus teclistamab at a dosage of 3.0 2 As a combination therapy, talquetamab and teclistamab show significant promise in the phase 1b/2 dose escalation and expansion in the RedirecTT-1 trial (NCT04586426).
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
Image credit: Cynthia | stock.adobe.com The Battle Over GLP-1 Compounding We are witnessing the most significant events in compounding history play out as some of the challenges to GLP-1 compounding are addressed in court. The discussion underway gets to the very essence of compounding itself.
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1 About the Author Monica Holmberg, PharmD, BCPS, is a pharmacist in Phoenix, Arizona, and a Pharmacy Times contributor. DOSAGE AND ADMINISTRATION The recommended dose of gepotidacin is 1500 mg orally twice daily for 5 days. The medication should be taken after a meal to reduce gastrointestinal intolerance.
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