European Pharmaceutical Review

NOVEMBER 28, 2024

Regulations rife with inconsistency The EU AI Act’s lack of precise definitions mirrors issues seen in the early days of the GDPR.

Documentation 105

Documentation Compounding 105

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 52

Compounding Sterile Compounds Packaging Labelling 52

Pharmaceutical Technology

NOVEMBER 1, 2022

Intrinsic Medicine has signed a definitive business combination agreement with special purpose acquisition (SPAC) firm Phoenix Biotech Acquisition to create a public company. The merged business’ cash resources are estimated to offer Intrinsic the capital to progress its lead compound, OM002, and other pipeline assets.

Compounding 59

Compounding 59

The Thyroid Pharmacist

JUNE 30, 2023

Interview With Dr. Mark Mandel To learn more, I decided to interview Dr. Mark Mandel, PharmD, compounding pharmacist, LDN expert, and fellow Midwestern University Chicago College of Pharmacy grad, on the effects of LDN in people with Hashimoto’s and autoimmunity. It’s a process and a journey, but it’s definitely worth it.

Compounding 98

Compounding Immunity Immunization Compounding Pharmacies 98

Welltopia Pharmacy

JUNE 16, 2023

Definition and purpose of Estriol cream Women starting the menopausal age will have hormonal changes, Introduction to Estriol Cream a.

Compounding 52

Compounding 52

European Pharmaceutical Review

OCTOBER 23, 2023

In most cases, formulation compounds represent a fixed starting point from which any changes can be implemented, whereas tableting process parameters as well as machine condition, can be managed and optimised to their best, combining the knowledge of the machine manufacturer with the experience of the pharmaceutical industry. cited 2023Oct].

Compounding 98

Compounding Pharmaceutical Manufacturing 98

Big Molecule Watch

SEPTEMBER 24, 2024

Under the Public Health and Service Act (PHSA), Congress amended the definition of “biological products” to include “proteins,” as well as products that are “analogous” to proteins. The FDA determined that, under its regulatory definition, only alpha amino acids are counted towards the “greater than 40 amino acids” threshold.

Dosage 49

Dosage Compounding Diabetes 49

PharmaShots

JUNE 15, 2023

The agreement combines Cullgen's uSMITE targeted protein degradation platform with Astellas' capabilities to develop multiple targeted protein degraders Ref: Businesswire | Image: Astellas Related News:- Astellas Entered into a Definitive Agreement to Acquire Iveric Bio for ~$5.9B PharmaShots!

Compounding 40

Compounding 40

Pharmaceutical Technology

JUNE 27, 2022

Ipsen has signed a definitive merger agreement to acquire all the outstanding shares of commercial-stage biopharmaceutical company Epizyme, for an initial total consideration of $247m. Furthermore, we are excited to bring on board epigenetic expertise and the SETD2 inhibitor, as well as several pre-clinical compounds into our portfolio.”.

Chemotherapy 59

Chemotherapy Compounding 59

European Pharmaceutical Review

NOVEMBER 10, 2022

However, the current terminology covers a broad field, with no widely agreed consensus on the definition. The requirement for complex medicines to be fluorescently labelled is another limitation of the method – labelling can be a complicated process, and there is a risk that it could change the behaviour of the compounds. Figure 1 ).

Labelling 105

Labelling Compounding 105

PharmD Live

MAY 13, 2024

Defining Polypharmacy: Variability and Impact Polypharmacy, the concurrent use of multiple medications, lacks a universal definition despite its prevalence. Understanding these definitions and categories helps clarify the challenges and necessary management strategies associated with polypharmacy, particularly among the elderly population.

Long-Term Care Facilities 105

Long-Term Care Facilities Diabetes Nursing Homes Prescription Filling 105

pharmaphorum

DECEMBER 23, 2020

Denali has been working on small-molecule compounds capable of crossing the blood-brain barrier and Biogen has bought a licence to co-develop and co-market compounds known as LRRK2 inhibitors in Parkinson’s disease.

Chemotherapy 96

Chemotherapy Compounding Vaccines 96

Pulses

AUGUST 31, 2023

Despite the increasing popularity, definitive classifications of these terms remain elusive, and too often, are used interchangeably. Definitions: Augmented reality (AR) involves superimposing computer-generated virtual images on the real world allowing learners to view and interact with the virtual content in real-time.

Medication Dispensing 78

Medication Dispensing Medication Labelling Packaging Labelling 78

European Pharmaceutical Review

JULY 4, 2024

It begs the question of why only two botanical drug products have obtained FDA approval and fulfilled the Botanical Guidance definition of a botanical product. The intricate nature of botanical products further compounds the challenge, demanding a paradigm shift in regulatory interpretation and QC standards.

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103

RX Note

JUNE 5, 2023

Workplace activity involves how healthcare workers use and handle the drug in the workplace - such as opening shipments, compounding, administering or cleaning up after use or spills. Oral hazardous drugs No crushing or compounding may be done in an unprotected environment. Consider having spill-response exercises or drills.

Compounding 52

Compounding Packaging Hospitals Chemotherapy 52

European Pharmaceutical Review

DECEMBER 21, 2022

Organic compounds are arguably the foundation of the pharmaceutical industry. All traditional small molecule pharmaceuticals include carbon building blocks” Organic compounds are arguably the foundation of the pharmaceutical industry.

Compounding 97

Compounding Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 97

Pharma in Brief

FEBRUARY 3, 2021

The 202 Patent: compound and use claims valid and infringed. Having regard to the definition in the specification, the Court rejected that proposition and agreed with BMS that “treatment is directed to ‘mammals’ – and any mammal will do.”. Construction. The claims were later amended and, when issued, were specific to apixaban.

Compounding 52

Compounding Documentation 52

epicur

MAY 6, 2024

But if it’s completely unavailable, start by looking at alternatives, whether compounded or a similar product. If something that is not an emergency product expires, I definitely like to evaluate it first before repurchasing the same thing again. Do we need to get a smaller container size next time?

Customer Service 52

Customer Service Compounding Chemotherapy Online Pharmacies 52

pharmaphorum

JANUARY 16, 2023

This is definitely not because all unmet need is addressed: the WHO reports that the three leading causes of death globally, and growing, are ischaemic heart disease, stroke, and chronic obstructive pulmonary disease. And all are predominantly prevented or treated with medicines that are decades old.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Compounding Vaccines 98

FDA Law Blog: Biosimilars

JANUARY 18, 2024

within the CSA’s definition of “marihuana” or “marijuana” based on FDA’s eight factor analysis. whether growing or not; its seeds; resin extracted from any part; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin. 21 U.S.C. § 802(16)(A). 21 U.S.C. § 802(16)(B).

Controlled Substances 69

Controlled Substances Chemotherapy Compounding Dosage 69

RX Note

FEBRUARY 8, 2024

Compounding and dispensing competencies. Remington The Science and Practice of Pharmacy, 2020 For more than 100 years, Remington: The Science and Practice of Pharmacy has been the definitive pharmacy reference. It covers Basic competencies including confidentiality, safety, and security.

Compounding 52

Compounding Hospitals Diabetes 52

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

The Final Guidance clarifies that, although both applicable drugs and selected drugs must be covered under a Discount Program agreement, selected drugs are excluded from the definition of an applicable drug, so they are not subject to applicable discounts during an MFP applicability year. Non-applicable drugs (e.g.,

Labelling 105

Labelling Drug Pricing Compounding Payment Processing 105

RX Note

JUNE 5, 2023

Phenylketonuria Risk Aspartame is catabolized to phenylalanine among other compounds, making it unsafe for consumption in individuals with phenylketonuria. Stability at High Temperature Aspartame is unstable at high temperatures and cannot be used for baking or cooking. reduced risk of dental caries) and possibly negative effects (e.g.,

Packaging 52

Packaging Compounding Diabetes 52

epicur

NOVEMBER 9, 2023

That’s where compounded medications have really made a difference for us in the shelters, such as compounded ponazuril or compounded doxycycline. Working for a municipal shelter, we had to create a contract where we’d have to establish a relationship with a compounder. We’d get a budget through a bid process.

Compounding 52

Compounding Vaccines 52

epicur

JULY 2, 2024

USP Guidelines The new USP Guidelines limit beyond-use dates (BUDs) for compounded drugs at all 503A compounding pharmacies. There definitely has been a learning curve, but at the end of the day, it’s been very rewarding. I also share how Epicur, as a partner, can prevent potential challenges they might be facing in each state.

Compounding 52

Compounding Compounding Pharmacies Communication Hospitals 52

The Thyroid Pharmacist

DECEMBER 2, 2022

My antibodies went from 1200 + down to under 100 since then and I’m taking lower and lower doses of my compounded meds and cytomel. There is a range of recipes and not just simple salads as previous review suggested (salmon and parsnip fish cakes are definitely a favourite). “I bought root cause about 8 months ago.

Compounding 91

Compounding Immunity Immunization 91

epicur

APRIL 24, 2024

However, with inventory being the second largest expense in a veterinary practice, especially with the fluctuating economy in the last several years, it has definitely come to the forefront. I think that a lot of times, practices look at compounded meds and consider them regular pharmaceuticals.

Compounding 40

Compounding Controlled Substances Communication Online Pharmacies 40

European Pharmaceutical Review

FEBRUARY 23, 2023

There is no definitive answer as to whether life sciences companies should, or should not, opt their EPs out of the UPC. On the contrary, keeping stronger patents, eg, compound patents, in and opting less robust, second‑medical‑use patents out may help favourably shape the jurisprudence.

Biosimilars 98

Biosimilars Compounding 98

epicur

OCTOBER 27, 2023

It’s definitely a two-way street! There still is a knowledge gap of what 503B means to the veterinary industry and the differences between a compounding pharmacy and an outsourcing facility. We have to be very focused on what we do. We host several webinars on a variety of topics that our sales team and customers enjoy and learn from.

Hospitals 52

Hospitals Compounding Compounding Pharmacies 52

The Thyroid Pharmacist

OCTOBER 7, 2022

Stevia is a natural sweetener derived from the plant Stevia rebaudiana , or “honey leaf,” which contains the sweet-tasting compounds known as steviol glycosides. 13,16,18) Given this, stevia definitely seems to be a better alternative to sugar! Stevioside and related compounds: therapeutic benefits beyond sweetness. 2008.09.007.

Diabetes 98

Diabetes Immunity Immunization Labelling 98

Viseven

AUGUST 29, 2024

5G technology bridges the gap by connecting these patients with pharmacists or caregivers through high-definition video. trillion, with a compound annual growth rate (CAGR) of 35.7%. HCPs will increasingly rely on exchanging high-definition videos and images, like mammograms and X-rays, to make clinical decisions remotely.

Communication 52

Communication Hospitals Pharmaceutical Companies Pharmaceutical Companies 52

Quality Matters

MARCH 1, 2024

USP has a long-standing history of healthcare standards including those for compounding preparations that are tailored to meet the unique needs of patients who may not otherwise have access to their medications.

Labelling 52

Labelling Compounding 52

pharmaphorum

AUGUST 27, 2021

Imagine a group of highly accomplished R&D leaders, each advocating for their own compounds in development and aiming to attract the most funding. If your employer doesn’t mandate that goal definition at the start of each business year, write down your key deliverables regardless.

Communication 52

Communication Compounding 52

epicur

MAY 16, 2024

I definitely see cases where they’ve been treating the eye for a month with no improvement, and within about a minute or two from running an exam I know what is going on. Sometimes, I see patients come in, and they have been using crazy compounded medication, and their eyes are irritated and red.

Compounding 52

Compounding Hospitals 52

The Thyroid Pharmacist

SEPTEMBER 1, 2023

The fluorine anion (negatively charged ion), or any of the compounds containing the anion, are termed fluorides. The fluoride in drinking water comes from the addition of a fluorine compound (usually sodium fluoride, sodium fluorosilicate, or fluorosilicic acid), which dissociates to release the F- ion.

Adverse Reactions 116

Adverse Reactions Compounding Chemotherapy Labelling 116

Pharma in Brief

JANUARY 25, 2023

Combination use : The FC found that a generic manufacturer’s single-compound product would induce infringement of claims to a combination therapy (see here ). Such cases typically concern “skinny labels” in which the generic seeks to avoid reference to indications related to the patented use.

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Biosimilars Dosage Labelling Compounding 52

Proxsys Rx

FEBRUARY 23, 2023

No two manufacturers do things exactly the same, compounding the difficulty of ensuring that all the proverbial T’s and I’s are crossed & dotted — particularly when you’re speaking a different language with each company. By definition, a restriction makes it harder to gain legal access to HRSA-approved 340B pricing.

Specialty Pharmacies 52

Specialty Pharmacies Hospitals Compounding 52