Pharmacy Times

JUNE 23, 2025

Along with the successful pivotal trials, Launch-HTN and Advance-HTN, and the ongoing open-label extension trial, these results comprise the core package for our planned NDA submission.” Explore-CKD established that lorundrostat 25 mg once daily has a favorable clinical profile for this patient population.

Pharmacy Technician

Pharmaceutical Commerce

AUGUST 14, 2025

Cencora and Antares Vision, a packaging and technology vendor, participated in the second phase of a program organized by the Axia Institute, an offshoot of Michigan State University that promotes RFID technology. RFID uses electronic tags that can be read from a distance without so-called line of sight, a limitation of current 2D barcodes.

Insurance Coverage and Processing

Pharmacy Times

JUNE 11, 2025

1,2 Image Credit: © stockdevil - stock.adobe.com Results from 2 single-dose, open-label, randomized phase 1 crossover studies of healthy adults served as the basis for this approval. Package insert. These trials were designed to establish bioequivalence between zanubrutinib capsules and zanubrutinib tablets. News Release.

Pharmacy Technician

PharmaTech

JUNE 25, 2025

link] Recent Videos Related Content Looking Beyond mRNA-based COVID-19 Vaccines to Innovative Therapeutics Cheryl Barton June 24th 2025 Article mRNA technologies offer great promise in immunotherapy and non-immunogenic applications. Text sign showing Industry News. The Impact of USP Chapter on Endotoxin Testing. PharmTech.com.

Dosage

PharmaTech

JULY 17, 2025

This summary of our extensive article on this topic—written by industry professionals Paul Pluta RPh, PhD, Alan Mancini RPh, Nishant Thakar, RPh, PharmD, and Varanya Chaiyaperm, RPh, PharmD—distills the essential technical and operational takeaways from a comprehensive, six-stage model of pharmaceutical compounding.

Compounding

The Thyroid Pharmacist

MARCH 7, 2025

to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), In this article, Ill share nine sneaky thyroid toxins that could be affecting your thyroid health and, more importantly, how you can minimize your exposure and swap for products with cleaner ingredients.

Health and Personal Care Stores

European Pharmaceutical Review

APRIL 19, 2023

A market report has identified that global demand for electronic smart packaging will reach $2.6 Smart packaging has potential for the integration of electronic functionality, enabling compliance, material identification, condition monitoring and asset tracking of pharmaceutical products. billion in 2033.

Packaging

Safe Biologics

NOVEMBER 12, 2023

6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. ASBM Letter to Congress Defends Interchangeability Standard In a letter to Senator Mike Lee (R-UT) dated September 27th, ASBM urged the Senator to reconsider his support for S.6 However, S.6

Biosimilars

Drug Patent Watch

DECEMBER 12, 2024

This article will delve into the key considerations and best practices for evaluating CDMO performance. This includes drug substance and drug product development, clinical trial logistics, product labeling, supply chain management, commercial packaging, and more.

Drug Development

Safe Biologics

DECEMBER 6, 2023

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. Read the full BioSpace article here.

Biosimilars

GMPSOP

AUGUST 11, 2024

This article explores the essential components of the clinical supply chain for investigational pharmaceutical products and medical devices and provides a comprehensive guide to maintaining the highest standards in clinical trials. Investigational materials are typically not manufactured or packaged in registered product-dedicated facilities.

Packaging

ID Stewardship

OCTOBER 14, 2024

In this article an infectious diseases pharmacist discusses 5 examples where challenging antibiotic workflows can be an issue. BCPS, BCIDP Article Posted October 2024, First Released in the October 2024 IDstewardship Newsletter 1. Read all about this in the product label here. More information on ganciclovir in the label here.

Labelling

GMPSOP

FEBRUARY 25, 2023

Starting materials are processed, sampled, tested, packaged, and released before the finished products are stacked on pharmacy shelves. Sampling is carried out on intermediate processed materials and tested to ensure those are formulated correctly, free from contamination and qualified for filling and packaging. as their visual aids.

Labelling

GMPSOP

SEPTEMBER 22, 2022

Acceptable Quality Limit is used to make an informed decision whether to accept or reject an incoming packaging components lot by assessing the lot size and types of defects found during a pre-determined level of inspection. 4.0%) A defect that is not likely to materially reduce the usability of the product for its intended purpose.

Packaging

FADIC

JULY 14, 2024

OTC drugs come in various forms, including tablets, capsules, creams, and liquids, and are generally labeled with clear instructions on proper usage and dosage. The FDA’s website provides a wealth of information on OTC drugs, including product labels, warnings, and recalls.

Adverse Reactions

RX Note

MARCH 23, 2023

Today, stability information can be obtained from manufacturer’s labelling information (such as in the package insert), the USP compounding monographs, or peer-reviewed articles and references , such as articles in American Journal of Health-System Pharmacy, the International Journal of Pharmaceutical Compounding.

Compounding

European Pharmaceutical Review

SEPTEMBER 2, 2022

This article explores just one aspect of the RMP, that of RMMs, and how their effectiveness is measured with Dr Sophie Jouaville, an associate principal at IQVIA working on the design and oversight of non-interventional real-world evidence (RWE) safety and health economics and outcomes research (HEOR) studies.

Adverse Reactions

GMPSOP

FEBRUARY 15, 2024

This article is to help all personnel maintain a state of alertness to make sure that the plant housekeeping is always kept at the peak of efficiency. They should place all discarded cardboard, paper, and corrugation from the Packaging Dept. Quality assurance inspectors destroy all unused labels and inserts from the Packaging Lines.

Documentation

National Association of Boards of Pharmacy

APRIL 10, 2024

Then, walk through each step of the practice of pharmacy such as data entry; drug utilization review; compounding; final association between the drug, the prescription, and the label (eg, the dispensing act); and patient counseling. Go through each step in the process until the prescription is picked up, mailed, or delivered to the patient.

Drug Utilization Review

The Thyroid Pharmacist

SEPTEMBER 6, 2023

You can learn more about infrared sauna contraindications on Sunlighten’s website , as well as in my article on Saunas and Hashimoto’s here. Personal Care : The Wellnesse line of haircare and toothpastes by Katie Wells (aka the “Wellness Mama”) contains high-quality, safe ingredients that are clearly labeled, so there are no surprises!

Health and Personal Care Stores

GMPSOP

DECEMBER 6, 2024

This article explores how to prevent chemical spills, respond to and manage spills, dispose of contaminated materials, report spills, and assign responsibilities to the spill response team. All waste generated during the cleanup should be disposed of properly in labeled bags, and the equipment used must be cleaned and stored appropriately.

Health and Personal Care Stores

Birth Control Pharmacist

SEPTEMBER 20, 2021

While not stated in the current package insert, data are emerging that support fewer breast tissue effects and breakthrough bleeding than older oral contraceptives. Nextstellis (Drospirenone and Estetrol) [package insert]. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2021/214154s000lbl.pdf. Accessed June 25, 2021.

Adverse Reactions

GMPSOP

JUNE 28, 2024

Packaging/labeling/Misbranding: 41 warnings vi. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019. This article will explore more elements of unplanned deviations than planned deviations. CGMP Deviation: 39 warnings ii. Adulterated API: 39 warnings iv.

Documentation

GMPSOP

OCTOBER 28, 2023

Packaging material specifications In the pharmaceutical industry, the requirements for pre-printed packaging materials must be well-defined and documented to ensure that you get the items you specified or ordered and that there are no mix-ups. A standard name and a unique item code define packaging materials.

Documentation

The Thyroid Pharmacist

NOVEMBER 11, 2022

In this article, I share some fun ideas for gifts you can give (or add to your own wishlist ;-)). Check out my article on How Adaptogenic Herbs Benefit Hashimoto’s to learn more.). It turns out that many of the ingredients in laundry detergent aren’t listed on the label (and can irritate one’s skin!), The foodie.

Labelling

The Thyroid Pharmacist

AUGUST 19, 2022

In this article, I’ll dive a little bit deeper into: How infections can act as Hashimoto’s triggers. 2-5) I’ll share more about this later in this article, but for now, I wanted to mention that this is why I look at hundreds of studies and patient cases before I dismiss a trigger after just one study. pylori affects Hashimoto’s.

Health and Personal Care Stores

GMPSOP

JULY 23, 2023

If you are completely unfamiliar with what is installation qualification then we suggest you read the article Validation in Pharmaceutical Industry first. If you would like to know more on how to prepare acceptance criteria to use using verification of common pharmaceuticals equipment please read our article on operational qualification.

Documentation

GMPSOP

MARCH 17, 2023

Table of Contents If you are looking for literary help to write an actionable procedure on corrective and preventive action for your workplace or school, this article will be a good place to start. Further to corrective action, the defective packaging (carton) lot was destroyed which was initially quarantined. Consider this scenario.

Documentation

GMPSOP

MAY 31, 2024

This article can help you understand who is responsible for preparing the validation master plan, the stages of the validation life cycle, the risk-based prioritization of validation items, how to prepare a validation schedule, and some practical examples. The process validation of formulated products (e.g., tablets, capsules, ointments, etc.)

Documentation

GMPSOP

DECEMBER 10, 2023

Particularly the printed packaging materials where product information is presented. Printed packaging materials typically include product names, active ingredients, concentration, batch numbers, expiry dates, registration numbers, barcodes, etc. Commonly used packaging materials are cartons, inserts, leaflets, printed foil, etc.

Packaging

PharmaTech

JUNE 23, 2025

Thakar Varanya Chaiyaperm View All News Article Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling. Part two discussion describes a simple medication order and demonstrates calculations and labeling for each bulk drug type. Pluta Nishant B. Mole calculations.

Compounding

GMPSOP

MARCH 3, 2024

Cross contamination in the pharmaceutical industry can be described as an accidental inclusion of product of another batch or unknown foreign material into a finished batch, which was not intended or not mentioned on the label. Store all labels and leaflets in a locked room. Cross contamination data that can make you nervous!

Health and Personal Care Stores

PharmaTech

JUNE 6, 2025

In these instances, gas phase sequencing of purified peptides (also known as Edman sequencing) can be performed to sequentially identify amino acids based on their chromatographic elution positions following specific, sequential chemical labeling. Article details Pharmaceutical Technology ® Volume 49, No. and Ziengenfuss, R.

Dosage

GMPSOP

NOVEMBER 15, 2024

Stability testing ensures that the manufactured products remain safe, pure, and effective throughout their shelf life if they are kept in specified packaging and under environmental conditions. They are necessary for the API testing method and will also have to be conducted for the formulated and packaged product.

Packaging

The Thyroid Pharmacist

JULY 29, 2022

In this article, you will learn: How we are exposed to unhealthy air quality, indoors and outdoors. Perhaps more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! (13, For sunscreens and other over-the-counter drugs, fragrances must be identified on the label.

Health and Personal Care Stores

European Pharmaceutical Review

FEBRUARY 23, 2023

This article presents an overview of Raman spectroscopy and details some of the developments of interest to the pharmaceutical sector. 11 Future methods are likely to require samples being collected, labelled, filtered and processed to obtain their spectra. Label-free, rapid and quantitative phenotyping of stress response in E.

Labelling

BioPharma Dive

JULY 14, 2025

PCI helps biopharmaceutical companies manufacture and package drug products used in clinical trials as well as commercially. You can unsubscribe at anytime. That funding was supported by a “significant reinvestment” from current backer Mubadala Investment Co. and reportedly values PCI at $10 billion, according to The Wall Street Journal.

Drug Pricing