ISPE

NOVEMBER 30, 2022

Some recent projects include upgrading a biologics manufacturing process facility and expanding manufacturing capabilities at an oral solid dosage facility. Nik has been a member of ISPE since 2004. Based in Canada, Cheme Engineering oversees projects from all over the world primarily in the biotech and pharma industry.

Dosage 52

Dosage Documentation Compounding 52

The Thyroid Pharmacist

MARCH 31, 2023

A study in 2004 found an association between the presence of a mood or anxiety disorder, and the presence of anti-TPO antibodies. [1] Published 2004 Aug 18. She had already seen some major improvements with her Hashimoto’s through the use of thyroid medications as well as eating a Paleo diet , yet her anxiety persisted.

Immunization 105

Immunization Dosage Documentation 105

The Thyroid Pharmacist

JULY 14, 2023

2] In some cases, the person will become hyperthyroid, and the dosage of their medications will need to be reduced. If they are already taking thyroid medications, they may find themselves overmedicated, and may need to work with their doctors to reduce their dosage of thyroid medications. References [1] Nanan R, Wall JR. Ross, DS.

Dosage 97

Dosage FDA Immunization Documentation 97

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

SEPTEMBER 11, 2023

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. September 2004. Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms.” September 2004. The fit-for-purpose and reduced-size POD units promote green manufacturing. 3 (2022):593–607. 2 (1 May 2005).

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

AUGUST 30, 2022

The Common Technical Document (CTD) for the Registration of Pharmaceuticals For Human Use: Quality—M4Q guidance covers the minimum requirements for submission of raw materials; however, certain regions have additional requirements. The absence of any of the listed documentation should be scientifically justified.

Documentation 52

Documentation FDA Packaging Communication 52

Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Throughout 2022, Novartis was at the opposing ends of legal cases.

Documentation 97

Documentation FDA Hospitals Dosage 97