European Pharmaceutical Review

SEPTEMBER 26, 2023

The regulatory package submitted to the EC included evidence derived extensive analytical characterisation. Tyruko ® has the same strength/dosage form, intravenous (IV) route of administration, dosing regimen and presentation as the reference medicine, according to Sandoz. Tysabri ® is a registered trademark of Biogen MA, Inc.

Biosimilars 59

Biosimilars Dosage Packaging 59

Quality Matters

NOVEMBER 27, 2023

While the FDA has not yet received reports of eye infections associated with these 29 products, the agency published a draft guidance in October 2023 titled “ Quality Considerations for Topical Ophthalmic Drug Products ,” marking the first instance of the FDA providing specific guidance for this product category.

Documentation 52

Documentation Packaging Dosage 52

Integra X Files

DECEMBER 19, 2022

The guidance goes on to delineate formulary provisions to ensure that Medicare enrollees in nursing homes are not disadvantaged by the nonavailability of dosage forms that are commonly required in the nursing home environment.

Nursing Homes 52

Nursing Homes Documentation Dosage Packaging 52

GMPSOP

MAY 26, 2023

Six steps process to implement change control management Pharmaceuticals quality assurance & validation procedures GMPSOP Six steps process to implement change control management Last modified: June 3, 2023 Table of Contents “It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change”.

Documentation 52

Documentation Packaging Communication Customer Service 52

GMPSOP

MAY 26, 2023

Six steps process to implement change control management Pharmaceuticals quality assurance & validation procedures GMPSOP Six steps process to implement change control management Last modified: May 28, 2023 Table of Contents “It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change”.

Documentation 52

Documentation Packaging Communication Customer Service 52

GMPSOP

OCTOBER 28, 2023

Packaging material specifications In the pharmaceutical industry, the requirements for pre-printed packaging materials must be well-defined and documented to ensure that you get the items you specified or ordered and that there are no mix-ups. A standard name and a unique item code define packaging materials.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

JUNE 16, 2023

Importance of acceptance criteria in analytical method transfer Pharmaceuticals quality assurance & validation procedures GMPSOP Importance of acceptance criteria in analytical method transfer Last modified: June 17, 2023 Table of Contents What is analytical method transfer?

Documentation 52

Documentation Dosage Communication Method Validation 52

PharmaTech

JUNE 6, 2025

Analytical Validation (ICH, 2023). With their technical and methodological improvements, advanced techniques provide valuable information on overall product mass profiles. With properly designed experiments, these analyses provide data that will be indicative of the quality of the manufacturing process and the product itself. Easton, R.L.

Dosage 52

Dosage Drug Development Documentation Biosimilars 52

PharmaTech

JUNE 9, 2025

Targeted Nanoscale Drug Delivery Systems For Melanoma Therapy. & Tech. 86, 104724. link] org/10.1016/j.jddst.2023.104724

Dosage 52

Dosage Drug Development Immunization Immunity 52

European Pharmaceutical Review

FEBRUARY 14, 2024

Intestinal bacteria ( microbiome ) concept Capsules are therefore the most common dosage form considered currently for LBP delivery due to their flexibility in selection of size during dose establishment and the ability to modify release profiles using well established coating systems. Gullifa G, Risoluti R, Mazzoni C, et al.

Dosage 97

Dosage Packaging Labelling Compounding 97

Quality Matters

JUNE 14, 2023

Out of the 550+ reported counterfeiting incidents, either customs seizures or police/health inspector raids were involved, and 60% of the seizures comprised more than 1,000 dosage units. kristine.gates… Wed, 06/14/2023 - 08:16 Supply Chain This amounts to more than 300,000 doses of counterfeit drugs intercepted.

Dosage 52

Dosage Packaging Documentation Hospitals 52

The Thyroid Pharmacist

OCTOBER 27, 2023

Follow package instructions. Follow package directions for each supplement. If you’re experiencing these symptoms, reduce your dosage to ⅛ teaspoon daily, increasing usage slowly, as tolerated, to get to the recommended label usage. The herb itself can be poisonous if ingested. and magnesium citrate before bedtime.

Health and Personal Care Stores 104

Health and Personal Care Stores Immunization Immunity Compounding 104

Quality Matters

JUNE 6, 2023

To facilitate a risk-based approach to supplier qualification, USP developed General Chapter Supplier Qualification , which includes excipients and will be effective in August 2023. kristine.gates… Tue, 06/06/2023 - 17:00 Supply Chain

Dosage 52

Dosage Packaging Documentation Drug Development 52

PharmaTech

JUNE 12, 2025

billion (1). billion (1).

Dosage 52

Dosage Drug Development Vaccines Packaging 52

PharmaTech

JUNE 11, 2025

TurboFil Introduces MediFil Cart as Standalone, Servo-Controlled Ceramic Vial Filler Patrick Lavery June 6th 2025 Article The company describes the compact system as ergonomically designed, providing precision dosing and production floor flexibility.

Dosage 52

Dosage Drug Development Packaging Vaccines 52

The Thyroid Pharmacist

MARCH 10, 2023

Be sure to follow the package directions and your practitioner’s guidance to determine the right dosage for you. Accessed January 25, 2023. Published 2014 Aug 19. doi:10.1371/journal.pone.0103490 0103490 [29] Alpert, JE, and Fava, M. Nutrition and Depression: The Role of Folate. January 1997. link] [30] Kennedy DO. 2016;8(2):68.

Health and Personal Care Stores 98

Health and Personal Care Stores Immunization Immunity Dosage 98

The Thyroid Pharmacist

APRIL 11, 2025

While it’s uncommon for people without celiac disease to completely stop taking thyroid medication solely by going gluten free, some do find they can reduce their dosage through a gluten-free diet. You can learn about the top probiotics that I recommend at the linked to article, along with dosage info and precautions.

Immunization 70

Immunization Immunity Dosage Diabetes 70