ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

Documentation 52

Documentation Dosage Packaging Communication 52

The Thyroid Pharmacist

JUNE 16, 2023

Black seed oil has likely been used as a medicinal herb for 3000 years or more, and its use has been documented in Ayurveda, Unani, Tibb, Siddha, and other systems of medicine. [4] 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. 2009; 1(2); 143-149. [22]

Compounding 116

Compounding Dosage Immunization Insurance 116

ISPE

SEPTEMBER 8, 2023

Published August 2009. en/documents/other/european-medicines-agencies-network-strategy-2025-protecting-public-health-time-rapid-change_en.pdf 11 European Medicines Agency. link] 3 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Published January 2023. 22 June 2023. EMA/321483/2020.

FDA 52

FDA Documentation Dosage Communication 52

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. This document catalogs and summarizes the various risks to the company. April 2009. November 2022. Guidance for Industry. March 2023.

Insurance 52

Insurance Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JULY 6, 2023

Going up in scale, in a CONTINUUS Pharmaceuticals and MIT collaboration, an end-to-end, QbD-driven integrated continuous manufacturing (ICM) pilot plant 8 was designed to produce both small molecule active pharmaceutical ingredient (API) and oral solid dosages. Deep Learning for Continuous Manufacturing of Pharmaceutical Solid Dosage Form.”

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. 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