Pharmacy Times

JUNE 23, 2025

Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. For submission consideration, manufacturers can petition the FDA for ANDA status if the requested change does not require safety or effectiveness studies.

Pharmacy Technician 26

Pharmacy Technician Compounding Pharmacies Dosage Hospitals 26

PharmaTech

JULY 17, 2025

3d render, number six glowing in the dark, pink blue neon light | Image Credit: © NeoLeo - stock.adobe.com Pharmaceutical compounding, particularly in 503A and 503B environments, involves complex formulation and regulatory challenges far beyond academic theory. antineoplastics, allergens).

Compounding 59

Compounding Pharmaceutical Manufacturing Dosage Drug Development 59

PharmaTech

JULY 23, 2025

In silico approaches for determination of ADMET properties have, therefore, become crucial to accelerating drug discovery and development efforts, allowing rapid evaluation of large numbers of compounds. “PK/PD

Dosage 52

Dosage Drug Development Compounding Pharmaceutical Manufacturing 52

European Pharmaceutical Review

FEBRUARY 9, 2023

Processes in pharmaceutical manufacturing such as processing, milling, grinding, and mixing, are associated with the generation of dust. The researchers highlighted that the risks of hazard exposure include danger to the health of operators and cross-contaminations during manufacturing.

Dosage 105

Dosage Pharmaceutical Manufacturing Compounding 105

Pharmaceutical Technology

MAY 11, 2008

TABLET FORMATS One of the problems with track and trace for pharmaceuticals across the world is the way drugs are dealt with on an item level in Europe and the US. In the US solid dosage forms are distributed as containers of tablets and these can only be coded on the container and not on a per-item basis.

Packaging 40

Packaging Labelling Pharmaceutical Companies Pharmaceutical Companies 40

GMPSOP

JUNE 9, 2024

Certain laboratory reagents are categorized as dangerous commodities, including but not limited to explosives and gases, combustible compounds, peroxides and oxidizing agents, infectious substances and poisons, radioactive materials, and corrosives. Reagents should only be used for the purposes for which they were designed.

Method Validation 52

Method Validation Documentation Health and Personal Care Stores Labelling 52

GMPSOP

OCTOBER 28, 2023

Quality is everyone’s responsibility, and it should pervade every aspect of pharmaceutical manufacture and packaging. Quality should not be tested into products; instead, it must be built in at each step of manufacture. Pharmaceutical manufacturers must integrate the key functions of the quality control process.

Documentation 52

Documentation Method Validation Packaging Data Entry 52