ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

Documentation 52

Documentation Dosage Packaging Communication 52

The Thyroid Pharmacist

DECEMBER 1, 2023

10] In Finland, the incidence of type 1 diabetes in Finnish children increased when the daily recommended dosage of vitamin D was reduced from 4000-5000 IU in 1964, to 400 IU in 1992. Vitamin D deficiency has been documented in Hashimoto’s, Graves’ disease, thyroid cancer, as well as postpartum thyroiditis. [13] Published 2018 Aug 16.

Immunization 98

Immunization Documentation Dosage 98

ISPE

OCTOBER 28, 2022

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. Paul indicated that in 2018, ICMRA introduced an Inspection Reliance Guideline which was adopted by PIC/S ( PICS Inspection Reliance Guidance ).

FDA 97

FDA Vaccines Documentation Dosage 97

ISPE

SEPTEMBER 11, 2023

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. 24 August 2018. Published 2018. Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms.” Current Opinion in Chemical Engineering 22 (2018):62–70. 6 November 2019. 16 February 2022.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

NOVEMBER 21, 2022

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. Paul indicated that in 2018, ICMRA introduced an Inspection Reliance Guideline which was adopted by PIC/S.

FDA 52

FDA Vaccines Documentation Dosage 52

ISPE

JULY 6, 2023

Vertex continued to invest in CM with two additional approved drugs—Symdeco/Symkevi in 2018 and Trikafta in 2019—with the same indication. A broader range of novel dosage forms can be developed for the patients, and even individualized manufacturing, without extensive alterations to the process. Published 24 September 2018.

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JULY 5, 2023

In addition to the FDA, health authorities in Canada, Europe, Australia, Japan, Switzerland, and New Zealand have also approved applications with CM for the production of solid oral dosage forms. End-to-end continuous processes flow from starting materials to finished dosage forms. 38 (May/June 2018): 40–41. 4 a b Byrn, S.,

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

ISPE

MAY 10, 2023

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. 10 April 2018. Published 5 April 2018. Lakerveld, B. Benyahia, P. Barton, R.

Chemotherapy 52

Chemotherapy Documentation Dosage Communication 52

The Thyroid Pharmacist

JANUARY 20, 2023

I recommend that you closely monitor your thyroid symptoms, thyroid hormones, and thyroid antibodies, and test hormone levels every six to 12 weeks, to ensure your thyroid medication dosage is optimized. Published 2018 Dec 9. doi:10.1155/2018/8198652 [47] Dun Y, Liu S, Zhang W, Xie M, Qiu L. Oxid Med Cell Longev.

HIV Treatment and Prevention Agents 98

HIV Treatment and Prevention Agents Immunization Compounding Documentation 98

The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition.

Documentation 98

Documentation Dosage FDA Communication 98

Pharmaceutical Technology

JANUARY 6, 2023

Last week, Novartis announced plans to pay $245 million to end a pay-for-delay legal battle that started in 2018. According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”.

Documentation 97

Documentation FDA Hospitals Dosage 97