Pharmaceutical Technology

JANUARY 6, 2023

The agreement outlined that Par would keep its generic equivalent off the market for as many as two years, delaying the generic launch till September 30, 2014. At the centre of the case was Gilenya’s ‘405 patent, which details methods for treating relapsing multiple sclerosis with a specific dosage of the drug.

Documentation 97

Documentation FDA Hospitals Dosage 97

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

SEPTEMBER 8, 2023

USA The FDA established the Emerging Technology Program (ETP) in 2014 and has actively promoted the program 8. en/documents/other/european-medicines-agencies-network-strategy-2025-protecting-public-health-time-rapid-change_en.pdf 11 European Medicines Agency. 22 June 2023. EMA/321483/2020. 3 July 2020. www.ema.europa.eu/en/documents/other/european-medicines-agencies-network-strategy-2025-protecting-public-health-time-rapid-change_en.pdf

FDA 52

FDA Documentation Dosage Communication 52

ISPE

JULY 5, 2023

In 2014, CDER established the Emerging Technology Program (ETP) within its Office of Pharmaceutical Quality to better facilitate the adoption of emerging technologies such as CM. End-to-end continuous processes flow from starting materials to finished dosage forms.

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

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 98

Dosage FDA Immunization Documentation 98

ISPE

JULY 6, 2023

For much of the pharmaceutical industry, batch manufacturing (BM) processes that have been relied upon for decades remain the preferred approach for most oral solid dosage (OSD) drug products. 176 (September 2014):54517–49. This document catalogs and summarizes the various risks to the company. Final Rule. Washington, D.C.:

Insurance 52

Insurance Documentation Pharmaceutical Companies Pharmaceutical Companies 52