The FDA Law Blog

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).

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The Thyroid Pharmacist

APRIL 28, 2023

While the body makes anabolic hormones naturally, and in some cases, bioidentical dosages can be prescribed safely to ensure that we are in a balanced anabolic state if we are deficient, there are great risks when the steroids are used in excessive doses to “bulk up,” as they push the body into a hyper anabolic state. 2004;7(4):405-410.

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The Thyroid Pharmacist

JULY 8, 2022

The good news is that supplementing with selenium at a therapeutic dosage, has been found to reduce thyroid antibodies, reduce thyroid symptoms, and improve overall well-being. (1-3). Half of the participants were given selenium supplementation at a dosage of 200 mcg per day, along with levothyroxine, for a 90-day period.

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ISPE

SEPTEMBER 11, 2023

Although the novelty of these modes of manufacturing has led to some definitional ambiguities, initial working definitions and terminology have been drafted by several regulators, trade organizations, and subject matter experts. POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy.

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The Thyroid Pharmacist

SEPTEMBER 23, 2022

Other plants also contain this organic compound, but aloe vera contains an especially large amount, with over 12 different anthraquinones. The active compounds found in aloe vera have been found to have immune-modulating benefits. You can read more about treating underlying infections to reverse Hashimoto’s here. Immune Health.

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ISPE

MARCH 29, 2023

TPP/QTPP and Definition of CQAs As illustrated above, a development narrative briefly summarizes the quality elements of the product that are designed to meet patient needs (TPP and QTPP) and is organized based on the product understanding, risk assessments, and development data used to justify the control strategy. CPP 5 Test DS identity (S.4.1)

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ISPE

MARCH 29, 2023

TPP/QTPP and Definition of CQAs As illustrated above, a development narrative briefly summarizes the quality elements of the product that are designed to meet patient needs (TPP and QTPP) and is organized based on the product understanding, risk assessments, and development data used to justify the control strategy. CPP 5 Test DS identity (S.4.1)

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The Thyroid Pharmacist

JULY 7, 2023

A dosage of 200 mcg per day has been found to reduce thyroid antibodies in clinical trials. [41] In a study done in 2010, NAC and 15-Deoxy-Prostaglandin J2 (a fatty acid compound with antioxidant and anti-inflammatory properties) exerted a protective effect against autoimmune thyroid destruction in vivo. [47]

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The Thyroid Pharmacist

JULY 20, 2023

While dietary adjustments and supplementation can definitely help, time and again, I see it’s not so easy for some people (and yes, it’s true – I am “some people”, too)! Anemia by definition is having a low level of red blood cells. The body needs red blood cells in order to get oxygen from the lungs, to the rest of the body.

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Pharmaceutical Technology

FEBRUARY 23, 2023

Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).

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