Pharmaceutical Technology

JULY 12, 2022

Nearly one out of four subjects in these two trials were enrolled in sites in Canada. offered statistically significant improvement compared to a vehicle on secondary endpoints, including on Intertriginous Psoriasis Area Severity Index-75, decline in itch, IGA Success and subject perceptions of symptoms.

Labelling 64

Labelling Immunity Immunization 64

Pharmacy Joe

JANUARY 28, 2024

A group of researchers recently published in Critical Care Medicine a multicenter retrospective observational study of 50 mg vs 100 mg alteplase for PE in order to expand the available data on this subject. The authors compared 98 patients who were treated with 100 mg alteplase with 186 patients who were treated with 50 mg.

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Inpatient Hospitals 52

European Pharmaceutical Review

JUNE 2, 2023

Data-driven models that are developed using multivariate data analysis (MVDA) and machine learning (ML) are subject of a lot of research. The refractometry-based PAT system In the research, the PAT system used is a novel advanced refractive index (RI) profiling technology. For instance. Williams et al.

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Express Pharma

MAY 7, 2024

The US has once again pulled up India for ‘inadequate IP enforcement’ India is one of seven countries to remain on the Priority Watch List of the annual “Special 301 Report” recently released by the US Trade Representative (USTR). lakh crore) in annual sales have lost or will lose patent exclusivity in the US during this decade.

Insurance Coverage and Processing 98

Insurance Coverage and Processing Vaccines Drug Pricing 98

pharmaphorum

SEPTEMBER 9, 2022

The impact of the digital programme on patients will be tracked through improvements in body mass index (BMI) and other variables in a study involving around 1,000 subjects, to gauge how well it is working over time. It is estimated that more than half (53%) of the adults living in the EU are considered to be overweight or obese.

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pharmaphorum

AUGUST 31, 2022

The FM71 trial was carried out in 96 male subjects with organic and psychological ED, with the gel compared to oral tadalafil (5 mg) over a 24-week period using endpoints agreed with the FDA. The company says MED3000 has a unique evaporative mode of action, stimulating nerve endings to cause an erection.

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pharmaphorum

FEBRUARY 8, 2022

NICE has backed use of the Wegovy (semaglutide) for people with a body mass index (BMI) of 35 kg/m2 or more and at least one weight-related ailment – such as high blood pressure, high cholesterol or diabetes – as part of a weight management programme involving exercise and a reduce-calorie diet. kg/m2 lower.

Labelling 106

Labelling Diabetes 106

Pharmaceutical Technology

MAY 24, 2023

Fewer treatment days are of paramount interest for obese patients as many suffer from other comorbidities, subjecting them to additional pharmacotherapies. It is an issue that the company faced in March 2022, which resulted in halted sales of Wegovy and a delay in launching in the EU.

Diabetes 52

Diabetes 52

pharmaphorum

AUGUST 24, 2022

” The head-to-head comparison was carried out in around 60 subjects recruited at a tinnitus support meeting – split roughly equally between the UpSilent and White Noise groups – over 12 weeks. Other groups have tried to tackle tinnitus using digital health interventions. Last month, UK startup Oto raised £2.8 million ($3.3

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FDA Law Blog: Biosimilars

JUNE 28, 2023

According to CVM, these claims would constitute drug claims and, therefore, animal foods with these types of claims would be regulated as animal drugs subject to a time-consuming and expensive premarket approval process. On October 18, 2022, CVM held a virtual listening session on the regulation of animal foods with certain types of claims.

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Labelling 45

Pharma in Brief

JANUARY 20, 2021

Gowning for in-person hearings remain subject to the Notice of February 6, 2017. Subject to the FC’s discretion, affidavits sworn or affirmed remotely using the modes deemed acceptable in any Superior Court of any province will be accepted for filing until further notice. Updated COVID-19 Practice Direction. Service of Documents.

Documentation 52

Documentation 52

FDA Law Blog: Biosimilars

MAY 15, 2023

The AAFCO OP includes FDA approved feed and color additives, substances that are subject to GRAS notifications (AGRNs), etc. On May 2, AAFCO announced that it had published its first installment of a common food index (CFI). In the United States, animal food (feed) regulations are enforced by state and federal regulatory officials.

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Labelling Documentation 45

pharmaphorum

JUNE 6, 2021

Wegovy has been approved by the US regulator for use alongside diet and exercise in adults aged with either obesity (body mass index of 30 or more) or who are overweight (BMI 27 or above) and have at least one weight-related ailment such as high blood pressure, high cholesterol or diabetes. billion.

Diabetes 95

Diabetes Dosage 95

Pharmaceutical Technology

JULY 14, 2022

This efficient packing leads to fewer air voids, increasing the material's bulk density and resulting in less available space into which granules can move when subjected to an applied stress. It is frequently carried out as a wet process, but the resultant wet mass has to be dried and milled to generate a processable product.

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Birth Control Pharmacist

SEPTEMBER 20, 2021

The limitations of Nextstellis is that it could be less effective in obese patients with a body mass index equal to or greater than 30 kg/ m 2. The Pearl Index for women with a BMI <30 was 2.57, and it was 2.94 1 The Pearl Index is equal to the number of women that get pregnant out of 100 women per year. Limitations of Use.

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Adverse Reactions Packaging Labelling Diabetes 52

European Pharmaceutical Review

DECEMBER 14, 2023

In the ever-evolving landscape of regulatory decisions, the quest for safeguarding public health remains paramount. Decisions to remove medicines from market are not taken lightly and are often based upon all evidence available to inform a benefit/risk balance. But over time, trends in what evidence is most available and therefore most used, change.

Medical Records 108

Medical Records Vaccines Hospitals Drug Development 108

Board Vitals - Pharmacist

APRIL 22, 2022

These reviews must be an original contribution for publication in a medical journal indexed by MEDLINE. . Completing your CME requirements does not have to be stressful or time consuming. Here are some of the top ways to earn CME quickly and easily. . Live CME Conferences . Try to plan accordingly. Regularly Scheduled Series .

Documentation 52

Documentation 52

pharmaphorum

AUGUST 27, 2020

of patients treated with tapinarof in the two trials, respectively, had either clear or almost clear skin, compared to 6% of subjects treated with the control cream. of patients treated with tapinarof in the two trials, respectively, had either clear or almost clear skin, compared to 6% of subjects treated with the control cream.

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pharmaphorum

JUNE 6, 2021

Wegovy has been approved by the US regulator for use alongside diet and exercise in adults aged with either obesity (body mass index of 30 or more) or who are overweight (BMI 27 or above) and have at least one weight-related ailment such as high blood pressure, high cholesterol or diabetes. billion.

Diabetes 52

Diabetes Dosage 52

pharmaphorum

SEPTEMBER 2, 2020

While the effects of COVID-19 have been devastating for many industries, its positive impact on accelerating the uptake of digital health technologies and virtual collaboration solutions is undeniable. The convenience of virtual collaboration. The convenience of virtual collaboration. Mobile proximity allows more flexibility.

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Communication Vaccines 128

GMPSOP

FEBRUARY 10, 2024

It is a GMP/ GLP requirement that all personnel be trained in the work appropriate to their role. FDA-regulated industries should prepare GMP Training policies and procedures for their employees outlining training approaches, scope, responsibilities and overall training system. Check out sample preview s. – Carry out agreed development plans.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Packaging Compounding 52

FDA Law Blog: Biosimilars

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers.

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Drug Pricing Biosimilars Dosage Documentation 45

ALiEM - Pharm Pearls

MARCH 7, 2024

Then test your skills on the ALiEMU course page to receive your PEM POCUS badge worth 2 hours of ALiEMU course credit. The pain is intermittent, sharp, severe, and associated with 2 episodes of nonbloody, nonbilious emesis. She has a normal HEENT, neck, cardiac, respiratory, and back examination. Lay the patient supine when possible.

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Labelling Communication 174

The Thyroid Pharmacist

DECEMBER 28, 2022

As far back as I can remember, I’ve wanted to help people with their health. I grew up watching my mom work as a medical doctor, and always admired her. In elementary school, I was introduced to the scientific method and thought: “This is it! This is what I’m going to do when I grow up!”. I’ve learned so much from my clients and readers.

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Immunity Immunization Doctor of Pharmacy Clinical Pharmacology 110

The Physician Pharmacist

OCTOBER 27, 2023

️ Prepare for an enlightening Episode 7 of The Physician Pharmacist Podcast Miniseries, where we sit down with Dr. Steven Berk, a seasoned Internal Medicine Physician with over 25 years of experience. A Glimpse into Pharmacy Academia : Discover the world of pharmacy academia and the contributions that pharmacists make to education and research.

Medical Schools 52

Medical Schools Medical Records Hospitals Clinical Pharmacology 52

The Thyroid Pharmacist

OCTOBER 7, 2022

When I began my health journey with nutrition, I was skeptical. Could giving up gluten, dairy, and sugar really make a difference? If these foods were that problematic, I would have certainly learned about them in pharmacy school, right? Why did I not know about this? But sugar can also be a major issue! You need to cut out the sugar.”.

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Diabetes Immunity Immunization Labelling 95

The Thyroid Pharmacist

APRIL 28, 2023

While I didn’t realize this at the time, muscle wasting is indeed a symptom that is more common in those with thyroid issues. [1] In my own practice, many of my clients have had some form of muscle complaint, often involving muscle loss, muscle weakness, pain, and/or cramps.

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Immunity Immunization Diabetes Dosage 99

GMPSOP

APRIL 3, 2023

Checkout sample preview s. Access to exclusive content for an affordable fee. Subscribe GMP documentation requirements in laboratory Pharmaceutical testing laboratories provide a vital function with regard to provision of accurate and reliable test results. In relation to GMP Documentation, US FDA CFR 211 Sec.

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Documentation Method Validation Compounding Data Entry 52

pharmaphorum

JULY 7, 2022

In trials involving around 200 subjects, SleepCheckRx algorithms correctly identified around 89% of patients with moderate to severe OSA – i.e. those with an apnoea-hypopnea index (AHI) greater than or equal to 15/hour – with a specificity of almost 78%. That is in the same ballpark as polysomnography testing.

Diabetes 106

Diabetes 106

pharmaphorum

JUNE 13, 2022

Along with Df scores, it also included demographic information such as age, sex, systolic blood pressure, body mass index and smoking status as well as genetic risk factors, to arrive at a risk score for each subject. ” Image by Paul Diaconu from Pixabay . . ” Image by Paul Diaconu from Pixabay . .”

Diabetes 98

Diabetes 98

GMPSOP

MARCH 25, 2024

Bespoke (custom-built) hardware should have a design specification and be subject to acceptance testing. As general guidance, computer system validation in a GMP environment can be explained as “all new and legacy computerized systems that affect regulatory compliance processes (i.e., Who should do what during Computer System Validation 1.

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Documentation Packaging Communication Pharmaceutical Companies 59

The Thyroid Pharmacist

AUGUST 18, 2023

I love the concept of using food as medicine — or as I like to call it, food pharmacology. I became a pharmacist because I was interested in the effects that different substances have on human physiology. Pharmacognosy” is the term we use for the study of medicines derived from natural sources. Curcumin is the active component in turmeric.

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Dosage Compounding Labelling Diabetes 98

FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

In this post, we summarize the purported basis for this claim as described in the proposed rule (PR) and assess the strength of potential legal challenges should a final rule be issued (see our prior posts on the proposed rule here and here ).

Hospitals 81

Hospitals Immunity Immunization 81

The Thyroid Pharmacist

JANUARY 6, 2023

Depression is a topic near and dear to my heart. Many moons ago, I lost a loved one to suicide… and while I’ll never understand the immense pain of a person in the moment before they choose to end their life, I can tell you that the loss leaves families and survivors (like me), in utter devastation and despair.

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Dosage Labelling Communication Compounding 121

Viseven

JULY 12, 2022

Content is king. Probably, you’ve heard these three words many times. But only a few know that it’s the title of Bill Gates’ essay published on the Microsoft website in 1996. Here’s a little excerpt from it: The Internet also allows information to be distributed worldwide at basically zero marginal cost to the publisher.

Communication 52

Communication Documentation Hospitals 52

The Thyroid Pharmacist

SEPTEMBER 9, 2022

Sure, the thyroid medication helped; instead of sleeping for 12 hours, I only needed 11 hours of sleep. But I didn’t stop there. At the time of my diagnosis, I was working as a consultant pharmacist and had become accustomed to researching emerging healthcare information. Finding a way to get myself better became my mission.

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Diabetes Dosage Compounding Immunity 98

RX Note

FEBRUARY 23, 2023

Ancora imparo: I am still learning. Disclaimer: Rx Note shall not be liable for any loss whatsoever arising from the use of information obtained from the website. The information provided is meant to act as a guide and should not substitute professional clinical judgement. insulins, inhalers, GTN, transdermal patches, etc.)

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HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 75