Pharmacy Times

JUNE 23, 2025

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.

Pharmacy Technician

Pharmacy Times

JULY 10, 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.

Pharmacy Technician

Pharmacy Times

JUNE 9, 2025

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. trillion economic impact in 2020. trillion economic impact in 2020.

Pharmacy Technician

Pharmacy Times

JULY 22, 2025

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.

Pharmacy Technician

Pharmacy Times

JUNE 17, 2025

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.

Dosage

Pharmacy Times

JULY 17, 2025

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.

Pharmacy Technician

Pharmacy Times

JUNE 20, 2025

For effective patient care, we need smart people to design workflows for operationalizing 505(b)(2) drugs, integrating the next biosimilar we have to stock, and managing the compounding of a new hazardous drug. We need people to coordinate and track prior authorizations, write persuasive appeal letters, and keep patients updated.

Pharmacy Technician

Pharmacy Times

JUNE 10, 2025

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!

Pharmacy Technician

Pharmacy Times

JUNE 19, 2025

Trends Pharmacol Sci. 2024;45(5):406-418. doi:10.1016/j.tips.2024.03.004

Pharmacy Technician

Pharmacy Times

JUNE 27, 2025

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 (..)

Pharmacy Technician

Pharmacy Times

JULY 7, 2025

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.

Pharmacy Technician

Express Pharma

JUNE 23, 2025

How to get it right -A practical framework Start with a Risk Assessment: Map out materials, dosage form, route of administration, and expected interactions. Real example: Injectable in a glass vial We supported a vaccine company using Type I glass vials they assumed were inert. Many Indian companies skip this step.

Packaging

Pharmacy Times

JUNE 13, 2025

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.

Chemotherapy

Pharmacy Times

JUNE 20, 2025

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.

Pharmacy Technician

Pharmacy Times

JUNE 16, 2025

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.

Biosimilars

Pharmacy Times

JUNE 30, 2025

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).

Pharmacy Technician

Pharmacy Times

JUNE 16, 2025

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).

Pharmacy Technician

Pharmacy Times

JUNE 18, 2025

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 (..)

Pharmacy Technician

Pharmacy Times

JULY 18, 2025

As depicted in Table 2 , if all of the following are true, then it is essentially a copy : same active pharmaceutical ingredient (API), same or easily substitutable dosage strength (this is set at greater than ±10%), and can be used by the same route of administration as prescribed for the compounded drug.

Compounding

PharmaTech

JUNE 24, 2025

cancer and vaccines), and non-immunogenic applications (e.g., cancer and vaccines), and non-immunogenic applications (e.g., Several types of mRNA-based vaccines have emerged, namely non-replicating linear mRNAs (NRM), self-amplifying mRNAs (saRNAs), and circular mRNAs (circRNAs). Types of messenger RNA (mRNA)-based vaccines.

Vaccines

PharmaTech

JUNE 27, 2025

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines Feliza Mirasol April 30th 2024 Podcast In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.

Dosage

PharmaTech

JULY 7, 2025

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines Feliza Mirasol April 30th 2024 Podcast In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.

Dosage

Express Pharma

NOVEMBER 26, 2024

.” Dr Veeramani, Chairman, Pharmexcil, said “ The Indian pharmaceutical industry stands as a global leader, exporting to over 200 countries and providing comprehensive solutions across APIs, finished dosages, clinical research, and pharmacovigilance. With exports nearing $27.84

Packaging

Pharmacy Times

JUNE 18, 2025

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 (..)

Pharmacy Technician

PharmaTech

JUNE 20, 2025

Sharing knowledge, exploring investments Key Takeaways Abu Dhabi signed MoUs with BI, Sanofi, and Abbott to expand vaccine R&D, local pharma production, and digital health capabilities. Abbott’s pact focuses on localizing pharma manufacturing, biosimilar development, and advancing UAE’s digital health initiatives. Press Release.

Dosage

Pharmacy Times

JULY 18, 2025

DOSAGE AND ADMINISTRATION The recommended dose of gepotidacin is 1500 mg orally twice daily for 5 days. Age, body weight, race, and sex have not been shown to have a clinically relevant effect on gepotidacin exposure. 1 About the Author Monica Holmberg, PharmD, BCPS, is a pharmacist in Phoenix, Arizona, and a Pharmacy Times contributor.

Pharmacy Technician

Quality Matters

JUNE 17, 2024

Biologics and biosimilars – the basics Biologic medicines – “biologics” for short. And what about “biosimilars” ? Read on to learn some of the basics about biologics, biosimilars and why patients taking them can be confident in their quality. What are biosimilars? They are given at the same strength and dosage.

Biosimilars

PharmaTech

JUNE 6, 2025

A magnifying glass examining a vintage vaccine vial surrounded by four minimalistic chart icons, symbolizing healthcare, medicine, and analytics in the context of global health monitoring. Biosimilars continue to build as a sector of this market with an estimated 2025 value in the region of US$42 billion (1). Specifications.

Dosage

Pharmaceutical Technology

SEPTEMBER 26, 2022

The company told GlobalData PharmSource: “The biosimilar facilities in Austria and Slovenia would continue to manufacture biosimilars for Sandoz under a contractual agreement with Novartis. This came after an attempted sell-off starting last October was met with no formal offers from a buyer.

Biosimilars

Pharma in Brief

JANUARY 25, 2023

With or without food: The FC rejected an innovator’s claim that a generic manufacturer would induce infringement of its patent claims to the use of an oral dosage form “with or without food or beverage intake”. In another action involving the same patent but a different generic manufacturer, the FC upheld the patent’s validity (see here ).

Biosimilars

National Association of Boards of Pharmacy

OCTOBER 2, 2024

As a medication expert, let your patients know you can educate them on how to take their medication, including discussing the correct dosage, frequency, and how to avoid an accident that could lead to an overdose. Get vaccinated Don’t let patients wait for a doctor’s appointment to get vaccinated!

Dosage

Pharmaceutical Technology

NOVEMBER 3, 2022

As of November 2, different dosage forms of the treatment remain on the FDA’s drug shortages list due to manufacturing challenges, with estimated recovery dates in March, June, and September 2023. But since these generics or biosimilars are often not too profitable, manufacturers require incentives, say Beavers and Page.

Dosage