FDA Law Blog: Biosimilars

NOVEMBER 7, 2023

” At least that’s this blogger’s reaction to the recent news that FTC sent out Notice letters to 10 different drug companies about the patent information they list in the Orange Book. As FTC explains in a Press Release , the Agency “challenged more than 100 patents” that it believes are improperly or inaccurately listed in the Orange Book.

Dosage 59

Dosage 59

Pharmacy Joe

APRIL 14, 2024

The study was done to compare apixaban with warfarin, but apixaban patients were further analyzed based on dosage. If you like this post, check out my book – A Pharmacist’s Guide to Inpatient Medical Emergencies: How to respond to code blue, rapid response calls, and other medical emergencies. <–

Inpatient 52

Inpatient Dosage 52

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

314.3 , codified in 2016, which defines strength as the “ total quantity of drug substance in mass or units of activity in a dosage unit or container closure” and/or “the concentration of the drug substance.” solid oral dosage forms),” which, FDA posits, suggests “that the terms have overlapping meanings.”

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Biosimilars Dosage 59

The Thyroid Pharmacist

AUGUST 23, 2023

Please note: Some people may need to increase their dosage of thiamine from 600 mg per day. It looked at the effect of thiamine on patients with Crohn’s disease and ulcerative colitis, and found that effective dosages ranged from 600 mg to 1,500 per day, depending on individual body size. [7]

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Dosage Labelling 98

RX Note

MARCH 28, 2024

Register Records under Poisons (Psychotropic Substances) Regulations 1989 Regulation 19 - Prescription Register for Psychotropic Substance The date on which the psychotropic substance was sold or supplied or administered and the serial number of the entry in such register The name and strength of the psychotropic substance and the quantity sold or (..)

Dosage 40

Dosage Hospitals Packaging Documentation 40

Pharmacy Joe

JUNE 29, 2022

In this episode, I’ll discuss Paxlovid and other novel dosage forms that should not be crushed but look like they can be. Two relatively new dosage form technologies are nanocrystals and amorphous solid dispersions. Aprepitant, sirolimus, and certain forms of fenofibrate are examples of nanocrystal dosage forms.

Dosage 52

Dosage Inpatient 52

RX Note

JUNE 3, 2023

Introduction The Ministry of Health Medicines Formulary (MOHMF), “Formulari Ubat Kementerian Kesihatan Malaysia (FUKKM)", or sometimes known as Blue Book, is a list of medications that we can use in Ministry of Health (MOH) facilities. It is typically updated 2-3 times a year to add, modify or delist the medications in it.

Adverse Reactions 40

Adverse Reactions Dosage Hospitals Labelling 40

FADIC

OCTOBER 24, 2023

Drug manufacturers also have to submit details about how the drug works in the human body, guidelines for dosage, and information on safety and side effects. Some OTC medications are available at a higher dosage with a prescription. However, misuse or exceeding recommended dosages can still result in adverse reactions.

Health and Personal Care Stores 52

Health and Personal Care Stores Insurance Coverage and Processing Labelling Dosage 52

The Thyroid Pharmacist

DECEMBER 16, 2022

I published my third book right before he turned one, and let me tell you, doing live interviews during the day while waking up every two hours all night, every night, was tough! I am excited to share that I finished my fourth book (also known as my first book as a mommy) in April of 2022, and it will be released in April 2023!

Immunity 62

Immunity Immunization Dosage 62

FADIC

JANUARY 12, 2023

Dosage:   Adults, elders, and children 16 years and over: Two tablets up to four times a day with a maximum of 8 tablets/ day. Apply 4 hours as a minimum safe interval between dosages. Dosage:   Menstruating women above 12 years: One-Two tablets up to three times a day as needed with a maximum of 6 tablets in 24 hours.

Dosage 52

Dosage Adverse Reactions Diabetes Vaccines 52

Pharmacy Joe

SEPTEMBER 24, 2023

This was defined as maintaining MAP ≥65 mm Hg for at least 6 hours without a need for an increase in continuous norepinephrine infusion vasoactive dosage. If you like this post, check out my book – A Pharmacist’s Guide to Inpatient Medical Emergencies: How to respond to code blue, rapid response calls, and other medical emergencies. <–

Inpatient 52

Inpatient Dosage 52

Pharmacy Joe

JUNE 29, 2022

In this episode, I’ll discuss Paxlovid and other novel dosage forms that should not be crushed but look like they can be. Two relatively new dosage form technologies are nanocrystals and amorphous solid dispersions. Aprepitant, sirolimus, and certain forms of fenofibrate are examples of nanocrystal dosage forms.

Dosage 40

Dosage Inpatient 40

FADIC

OCTOBER 20, 2023

Patient Counseling Points for Vitamins: Vitamin A: Advise patients to follow the recommended dosage, as excessive intake can lead to toxicity. Guide dosage and administration: Pharmacists offer personalized recommendations on the appropriate dosage, frequency, and administration of the vitamins.

Immunity 89

Immunity Immunization Dosage Patient Counseling 89

Pharmacy Joe

NOVEMBER 10, 2021

The colchicine dosage was also reduced by 50% for patients under 70 kg or with creatinine clearance under 30 mL/min. If you like this post, check out my book – A Pharmacist’s Guide to Inpatient Medical Emergencies: How to respond to code blue, rapid response calls, and other medical emergencies. <–

Hospitals 40

Hospitals Inpatient Dosage Labelling 40

RX Note

JUNE 10, 2023

You may learn more of this in Geriatric Pharmacy Pocket Book, 2021. Geriatric Giants In 1965, Bernard Isaacs coined the term "Geriatric Giants". It is often used to refer to health impairments that appear in the elderly (do not fit into any specific organ-based disease categories) and often have multifactorial causes.

Nursing Homes 52

Nursing Homes Dosage Hospitals Vaccines 52

The Thyroid Pharmacist

AUGUST 11, 2023

Recommendations for Those on T4-Only Medications T4-only medication (such as Synthroid, Levoxyl, Tirosint, Eltroxin, and generic levothyroxine) has a five- to nine-day half-life, which means that once you have become stable on the current dosage, it can take up to nine days for 50 percent of the dose to clear the body.

Dosage 97

Dosage Compounding Diabetes 97

FADIC

OCTOBER 20, 2023

Optimizing therapeutic outcomes: Pharmacists recommend OTC products and provide proper guidance on their correct usage and dosage. Patient advocacy: Pharmacists advocate for their patients’ health and well-being. They educate customers about potential side effects, duration of use, and when to seek medical advice.

Health and Personal Care Stores 98

Health and Personal Care Stores Grocery Stores Labelling Dosage 98

Big Molecule Watch

SEPTEMBER 25, 2023

indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration) described in its Full Prescribing Information.” FDA further states that “information about interchangeability is more appropriately located in the Purple Book rather than labeling.”

Labelling 62

Labelling Biosimilars Adverse Reactions Dosage 62

European Pharmaceutical Review

OCTOBER 19, 2022

FDA highlighted that over three quarters of new patents in the Orange Book between 2005 and 2015 were assigned to existing drugs. Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book. 10 There is a fear that such practices discourage innovative approaches, impacting on patient welfare. September 10, 2021.

Biosimilars 71

Biosimilars Dosage Drug Pricing Pharmaceutical Companies 71

Pharmacy Joe

JANUARY 9, 2022

The study was done to compare apixaban with warfarin, but apixaban patients were further analyzed based on dosage. If you like this post, check out my book – A Pharmacist’s Guide to Inpatient Medical Emergencies: How to respond to code blue, rapid response calls, and other medical emergencies. <–

Inpatient 40

Inpatient Dosage 40

RX Note

JANUARY 21, 2023

Adverse Drug Reaction Drug Induced Diseases, 2018 Meyler's Side Effects of Drugs, 2015 Antibiotics The Sanford Guide to Antimicrobial Therapy, 2022 Breastfeeding Briggs' Drugs in Pregnancy and Lactation, 2021 Hale's Medications and Mothers' Milk, 2021 Clinical Practice Applied Therapeutics, 2018 Conn’s Current Therapy, 2022 Current Medical Diagnosis (..)

Compounding 40

Compounding Community Pharmacies Clinical Pharmacology Dosage 40

Pharmacy Joe

DECEMBER 25, 2022

The serum levels of famotidine are known to be elevated in the setting of renal failure and a dosage reduction is aimed at reducing potential side effects including confusion and delirium. Typically, the dose of famotidine is reduced by 50% in patients with a creatinine clearance less than 50 mL/min.

Adverse Reactions 52

Adverse Reactions Inpatient Dosage Hospitals 52

The Thyroid Pharmacist

DECEMBER 29, 2023

I compare it to two other big years in my journey as a healer: 2013 – When I got myself into remission from Hashimoto’s, published a book on how to do so, and started the thyroidpharmacist.com website to help others do the same. Boulardii , and leaky gut support. Got Acid Reflux? And Hashimoto’s?

Adverse Reactions 54

Adverse Reactions Immunity Immunization Diabetes 54

Digital Pharmacist

SEPTEMBER 13, 2023

This complexity could involve taking medications with specific timing or dosage requirements, dealing with potential drug interactions, or experiencing side effects. Allowing patients to easily book MTM consultations through your website or app, provides patients with flexible scheduling options and reduces pharmacy no-shows.

Medication Therapy Management (MTM) 52

Medication Therapy Management (MTM) Communication Community Pharmacies Dosage 52

Quality Matters

JUNE 26, 2023

The same potential benefits can apply for so-called “complex generics” (CGx), which are generic drug products that have a complex active ingredient, formulation, dosage form, route of delivery, or are part of a drug/device combination. FDA publishes Product Specific Guidances (PSGs).The The value of U.S.

Dosage 52

Dosage Generic Medicine Labelling 52

The Thyroid Pharmacist

DECEMBER 15, 2023

Those that did not see any improvement may not have been dosed adequately, as betaine with pepsin dosages needs to be individualized. Takeaway The connection between low stomach acid and Hashimoto’s was a huge “AHA” moment for me, and led me to write my first book. References [1] Daher R, Yazbeck T, Jaoude JB, Abboud B.

Immunity 98

Immunity Immunization Dosage 98

Pharmacy Joe

JANUARY 10, 2021

Either FDA approval of a lower dosage size or an automatic substitution policy would likely be required to get IV ketorolac doses down to 10 mg routinely. If you like this post, check out my book – A Pharmacist’s Guide to Inpatient Medical Emergencies: How to respond to code blue, rapid response calls, and other medical emergencies. <–

Clinical Pharmacology 40

Clinical Pharmacology Inpatient Dosage Documentation 40

Pharmacy Joe

DECEMBER 25, 2022

The serum levels of famotidine are known to be elevated in the setting of renal failure and a dosage reduction is aimed at reducing potential side effects including confusion and delirium. Typically, the dose of famotidine is reduced by 50% in patients with a creatinine clearance less than 50 mL/min.

Adverse Reactions 40

Adverse Reactions Inpatient Dosage Hospitals 40

The Thyroid Pharmacist

MARCH 31, 2023

For more guidance on supporting your adrenals and your body’s stress response, I recommend checking out my newest book, Adrenal Transformation Protocol. The book provides a four-week program that has proven to be transformative for anxiety, with 86 percent of participants reporting reduced anxiety. It’s available for preorder now.

Immunity 105

Immunity Immunization Dosage Documentation 105

Pharmacy Friday Pearls

OCTOBER 3, 2022

x Eisenkraft JB, Book WJ, Mann SM, Papatestas AE, Hubbard M. TOF monitoring)given variability of response in each patient Sugammadex is the recommended reversal agent. Ann Emerg Med. 2005;45(2):225-226. doi:10.1016/j.annemergmed.2004.08.045 2004.08.045 Chan KH, Yang MW, Huang MH, et al. Acta Anaesthesiol Scand. 1993;37(7):679-682.

Dosage 52

Dosage 52

Pharmacy Joe

DECEMBER 16, 2020

This was defined as maintaining MAP ≥65 mm Hg for at least 6 hours without a need for an increase in continuous norepinephrine infusion vasoactive dosage. If you like this post, check out my book – A Pharmacist’s Guide to Inpatient Medical Emergencies: How to respond to code blue, rapid response calls, and other medical emergencies. <–

Inpatient 40

Inpatient Dosage 40

FADIC

OCTOBER 20, 2023

■ clinical pharmacy services review of treatment chart for appropriate indications drug dosing, dosage form, drug duplication, drug interactions, and drug allergies. Check Now the FADIC Book store and Buy books in different specialities. Core 4- Intervention and/or Referral 1.■   J Geriatr Cardiol.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Medication Therapy Management (MTM) Medical Records 52

The Thyroid Pharmacist

JUNE 16, 2023

The trial used dosages of 1, 2 and 3 grams of black seed oil per day, and found that the 2 gram per day dose was the most effective. A 2 gram dosage can be measured with the scoop that is usually provided. Additionally, insulin resistance was reduced and beta cell function increased. Again, don’t add it to smoothies!

Diabetes 111

Diabetes Dosage Compounding Immunity 111

Fusion Pharmacy

FEBRUARY 28, 2023

Then, once the ninety days are complete, we move you to a maintenance routine and dosage. George UT 84790 Book an Appointment Today! Just like getting up every morning and taking your daily vitamin, you’ll take your allergy drops. With every new patient, we start with an easy-to-follow, ninety-day starter kit.

Compounding Pharmacies 52

Compounding Pharmacies Compounding Immunity Immunization 52

The Thyroid Pharmacist

OCTOBER 1, 2022

However, in this article, I offer a brief overview of each, along with recommended products and dosages. Please note: All dosage recommendations in this article are intended for adults. Precautions: Thiamine is generally safe if taken in the recommended dosages. Recommended Supplement: Benfomax from Pure Encapsulations.

Adverse Reactions 98

Adverse Reactions Dosage Immunity Immunization 98

The Thyroid Pharmacist

NOVEMBER 29, 2023

This is because I had learned about various adulterants found in supplements, how some supplement manufacturers don’t actually put the products that are on the label in the bottle, or that the dosages listed on the label may be completely different from what’s in the products.

Health and Personal Care Stores 54

Health and Personal Care Stores Immunity Immunization Labelling 54

pharmacy mentor

FEBRUARY 14, 2023

Insulin – Monitoring blood glucose levels in people with diabetes and provide real-time feedback on insulin dosage and glucose levels. Book in a consultation call with our Diagnose and Prescribe team. Cardiovascular – Wearable devices can be used to monitor heart rate, blood pressure, and other cardiovascular indicators.

Community Pharmacies 52

Community Pharmacies Health and Personal Care Stores Dosage Diabetes 52