European Pharmaceutical Review

DECEMBER 13, 2022

However, this issue was first reported over 80 years ago in 1937 (sulfanilamide elixir poisoning incident) 2 and was responsible for the deaths of over 100 people in the US. It aims to control the quality from the point at which the material is designated for pharmaceutical use through to the end user. About the author.

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Compounding FDA Packaging 94

ISPE

SEPTEMBER 8, 2023

The Drug Shortages Prevention Model is a crucial step forward in ensuring that patients have access to the medicines they need. By providing guidance for manufacturers to prevent and mitigate potential shortages, the model will improve patient access to life-sustaining medicines and the reliability of supply.”

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Documentation 91

The People's Pharmacy

JUNE 26, 2023

We frequently write about some of our (and your) favorite remedies, such as purple pectin. Other readers have also shared your concern about the sugar in grape juice. I read in your column about mixing powdered fruit pectin with boiling water for aching joint relief. I would like to try it, but I have diabetes. 25, 2023 ).

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Compounding 61

European Pharmaceutical Review

OCTOBER 19, 2022

2 Recently, the US Patent and Trademark Office (US PTO) reiterated the concern that patents have been “misused to inhibit and delay – for years and even decades – competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.” About the author. He is now an independent GMC consultant. References.

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FDA Dosage Pharmaceutical Companies Pharmaceutical Companies 76

PharmaShots

APRIL 20, 2023

Shots: Paul talked about the approval of the Lyumjev Injection for the improvement of glycemic control in children and adolescents with diabetes. Smriti: Brief us about the study design of the P-III (PRONTO-Peds) clinical trial evaluating the Lyumjev Injection. Image source: Canva About the Author: Paul K.

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European Pharmaceutical Review

MAY 4, 2023

They are not US Food and Drug Administration (FDA)-approved for these patients due to the lack of benefit. 6 Precision medicine also offers the opportunity for more effective treatments targeted against the biological mechanisms causing disease, rather than the usual trial and error approach. Personalized medicine at FDA.

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Immunization Chemotherapy FDA 92

pharmaphorum

JANUARY 11, 2023

Asked about the impetus behind Verseon’s work in the sector, Prakash explained that he began the company “to change the way the world finds new drugs”. Using physics-based molecular modelling, we determine whether new molecules will bind to a target protein without having to first make them in the lab.”. Not an unambitious goal.

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Compounding 122

STAT

JULY 10, 2023

The 53-year-old chemistry professor had been hovering between 275 and 295 pounds for most of his adult life. Around Thanksgiving 2021, Fernandez’s doctor approached him about trying something different: a new weight loss drug called Wegovy. At 5’10”, that made him obese by most body mass index calculations.

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Communication 98

European Pharmaceutical Review

JUNE 29, 2023

A reduced global inspections rate in a post-pandemic world further augment the challenge; in 2022 the US Food and Drug Administration (FDA) inspected only six percent of approximately 2,800 overseas manufacturers. 2 Another ARB affected by the recall, losartan, was at the time, the ninth-most prescribed drug in the US.

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ISPE

MAY 10, 2023

Growing up I heard stories about both, and my goal became to not only join the pharmaceutical industry, but to work to make innovative medicine accessible to everyone, and to lower the cost of the medicine as much as we can from the manufacturing perspective.” After I obtained my Ph.D.

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Method Validation FDA 52

The People's Pharmacy

APRIL 16, 2023

Unfortunately, many of the medicines you might take for relief can have unpleasant side effects. As just one example, you should use decongestant nasal sprays for no more than a few days. Otherwise, you could develop rebound congestion and find it difficult to stop using the spray. How do you manage your allergy symptoms?

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Compounding 60

The Checkup by Singlecare

DECEMBER 18, 2023

According to NIH , 75% of Americans are coffee drinkers, and almost 50% of us drink it daily. Because coffee is so widely consumed you likely take time to think about how it affects your body in the long-term. So, who should be thinking about how their morning cup of joe impacts cholesterol?

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Compounding 105

pharmaphorum

JANUARY 29, 2021

Sangamo CEO Sandy Macrae told us how his company is being cautious about the hype and finding ways to be financially viable in an emerging space. The genomic medicine journey. First of all it will be used for ultra-rare monogenic disease. That said, Macrae notes that the industry needs to be cautious about this hype. “We

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Documentation 145

pharmaphorum

JANUARY 13, 2023

And they have to do it early because regulators are just as interested in their chemistry, manufacturing, and control (CMC) as their efficacy data. If you’ll forgive a slightly US-centric section, a lot of breath this week was spent griping about the US legislative branch. Ups and downs of government – IRA.

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FDA Immunization Vaccines 98

Pharmaceutical Technology

JUNE 24, 2022

5, there may be enough overlap for the bivalent vaccine to offer protection against all the subvariants, says Dr Prathit Kulkarni, assistant professor of medicine in infectious diseases at Baylor College of Medicine. The FDA did not respond to a comment request from Pharmaceutical Technology about any review plans.

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ISPE

MAY 10, 2023

Merck supplies over 150 billion doses of life-enhancing medicines and vaccines (human and animal health) to over 140 countries. Tell us about your journey and the challenges you faced as you got to your current position. It was about agility, constant innovation, and resiliency. Where will technology lead us?

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Vaccines 52

European Pharmaceutical Review

DECEMBER 1, 2023

During CPHI Barcelona, EPR Editor Caroline Peachey asked Anil Kane, Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific about the dynamic landscape of pharmaceutical drug development. Prefilled syringes bring a range of benefits.

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Dosage Process Improvement FDA 85

pharmaphorum

SEPTEMBER 3, 2021

Prof Osborne spoke to pharmaphorum about the therapy areas that could most benefit from medical music, how health services are now approaching the area and his own work on technology that predicts how music make us feel. Are you currently in discussions with health services or the pharma sector about this?

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Labelling 64

European Pharmaceutical Review

AUGUST 22, 2022

The European Medicines Agency (EMA) advocates 18 ng/day 6 as the default AI, where the US Food and Drug Administration (FDA) supports a value of 26.5 ppb in the US Pharmacopeia (USP). About the author. European Directorate for the Quality of Medicines & HealthCare. ng/day for novel API nitrosamines. References.

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Dosage Compounding FDA 59

pharmaphorum

AUGUST 10, 2020

Our behaviour patterns shape the conscious and unconscious decisions we make about our health and are often an indicator of future health outcomes. Great leaps have been made in patient outcomes – but further growth will require us to use a deeper understanding of behaviour to make these gains more sustainable”.

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Pharmaceutical Companies Pharmaceutical Companies 124

The Physician Pharmacist

SEPTEMBER 26, 2023

️ Join us in today's enlightening episode as we sit down with Dr. Tess Calcagno, a remarkable individual who has journeyed from the realm of pharmacy to the challenging world of medical school. We're here to unpack some of these details and open your eyes to the possibility of a career in both pharmacy and medicine.

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Medical Schools Communication Hospitals Patient Care 52

The People's Pharmacy

APRIL 24, 2023

Readers of our syndicated newspaper column have asked us for affordable and benign suggestions. I have been feeling very anxious about being stuck at home because of the coronavirus. My thumbs look awful and my wife gives me a lot of grief about them. All the stress has led me to start biting my nails again.

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Compounding 57

pharmaphorum

APRIL 28, 2021

To explore how data science techniques like text mining can accelerate research into an area like pancreatic cancer, Elsevier developed a new research report using text mining to identify the emerging trends in pancreatic cancer literature over the last two years. Understanding more about the disease and what determines poor patient outcomes.

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Immunization 105

The People's Pharmacy

MAY 1, 2023

His book, The Shocking Truth About Pharmacy: A Pharmacist Reveals All the Disturbing Secrets , can be downloaded in its entirety at Amazon for 99 cents. In my experience, pharmacists are usually much more positive about pharmaceuticals in our conversations with our customers in comparison to our conversations with close friends and family.

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Health and Personal Care Stores Insurance Refill Authorization Insurance Coverage 64

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. Berk sheds light on the rewards and responsibilities of this critical role. Don't miss this opportunity to be inspired and informed!

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Medical Schools Medical Records Hospitals Patient Care 52

pharmaphorum

JANUARY 17, 2023

Scully outlined that the reason that the liver is currently often targeted is due to the fact that the lipid nanoparticles used for delivery typically accumulate in the organ when administered systemically. Liberate was founded this year in Boston, US, with seeding funds from Khosla Ventures. Building a base.

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Vaccines Immunization 93

The Physician Pharmacist

OCTOBER 19, 2023

️ Join us for an inspiring and informative Episode 6 of The Physician Pharmacist Podcast, where we have the privilege of sitting down with Dr. Brandon J. In this episode, we delve into Dr. Smith's personal journey into the world of medicine, a journey that included pursuing fellowship training during the challenging COVID-19 Pandemic.

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Medical Schools Hospitals Patient Care Community Pharmacies 52

BuzzRx

OCTOBER 3, 2022

Many of us avoid going to the doctor, especially when nothing’s wrong. Please continue reading to learn more about what to expect during a routine physical exam. Your doctor may perform an extremities exam by moving your limbs to check joint movements, ask you questions about sensations, or use a rubber hammer to check reflexes.

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Vaccines 52

The Thyroid Pharmacist

MARCH 31, 2023

If medications can help someone feel better and get through a difficult time in their lives while the benefits outweigh the risks, then we should consider their use. Alcohol can lower our natural levels of inhibition while also making us less self-conscious and more bubbly. Blood sugar swings can put us on an emotional rollercoaster.

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Immunization Dosage Documentation 105

European Pharmaceutical Review

JUNE 24, 2022

The US Food and Drug Administration (FDA) requires that manufacturers establish whether nitrosamines, including NDSRIs, could be present in active pharmaceutical ingredients (APIs) and drug products, using the “three-step mitigation strategy described in the agency’s guidance”. About the author. References. Sandoz, Inc.

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FDA Documentation Compounding 52

IDStewardship

NOVEMBER 29, 2023

In this article the host of the Let’s Talk Micro Podcast (Luis Plaza Rios) is interviewed about his experience and learning clinical microbiology using podcasting via the Let’s Talk Micro podcast. I catch the podcast on Amazon music, but there are many ways to find it and learn about what is new on social media.

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Patient Care Hospitals Packaging Communication 222

European Pharmaceutical Review

FEBRUARY 24, 2023

The risks linked to contamination have led regulatory bodies, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to implement strict requirements on process characterisation and validation. About the author Mareia Frost, PhD is Director and Scientific Leader at Abenza.

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FDA 87

The Thyroid Pharmacist

OCTOBER 1, 2022

In this article, you’ll learn more about: Why we have nutrient deficiencies. For more in-depth information, I encourage you to read these linked articles about each nutrient. I recently received a letter from a reader who started on disability due to her thyroid fatigue and, with the use of thiamine, was able to return back to work!

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The Physician Pharmacist

NOVEMBER 2, 2023

Dr. Harris wears multiple hats as a board-certified internal medicine physician, pharmacist, professional speaker, investor, and the charismatic host of the Strive For Great Health Podcast. Medical Expertise : With board certification in internal medicine, Dr. Harris brings a wealth of medical knowledge to his endeavors.

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Medical Schools Compounding Hospitals Compounding Pharmacies 52

European Pharmaceutical Review

NOVEMBER 7, 2023

1 More specifically, patents relating to life sciences inventions are designated by International Patent Classifications (A) human necessities (which includes pharmaceuticals and medical devices, or (C) chemistry and metallurgy, which includes biochemistry, microbiology and genetic engineering, or a combination of both (A) and (C).

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pharmaphorum

JUNE 28, 2021

In the US alone, care of CKD patients cost more than $84bn in 2019, representing a staggering 20% of all Medicare spending in those aged 65 or older. Put even more starkly: patients with kidney failure represent 1% of the US Medicare population but account for 7% of the overall Medicare budget. About the authors.

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ISPE

MARCH 8, 2023

1 UK Medicines and Healthcare Products Regulatory Agency. “A A Guide to What Is a Medicinal Product.” link] To date, numerous case studies 2 , 3 , 4 , 5 , 6 have been completed on contaminated medicinal products and contaminants that may be useful in identifying and evaluating methods to control and manage contamination.

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Compounding Compounding Pharmacies Packaging FDA 52