Pharmaceutical Technology

JANUARY 6, 2023

Formulating products that have the proper composition, viscosity, texture, and stability, and can also be shown to be safe and effective, is both a science and an art. Without proper precautions, knowledge gaps can occur and important details may be overlooked when a product is transferred from one site to another. Simplicity matters.

Production 130

Production Manufacturing Development Bioequivalency 130

Camargo

DECEMBER 22, 2021

One of Camargo’s differentiating offerings is the portfolio analysis, a high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability of each product within a sponsor’s portfolio. Each product is unique, and so is the associated development strategy. Why Conduct a Portfolio Analysis?

Bioequivalency 169

Bioequivalency Production Genotoxicity In-Vivo 169

Camargo

FEBRUARY 10, 2021

Given that it can take up to 20 years for a final product to be approved, it is unsurprising that drug attrition rates are very high. Pharmacokinetics (PK) and bioequivalence (BE) studies serve as the foundation of determining the fate of drug products. Pharmacokinetic Modeling: Non-Linear Mixed Effects Modeling.

Production 133

Production Bioavailability In-Vivo In-Vitro 133

Drug Patent Watch

DECEMBER 10, 2024

The Importance of Scientific Expertise Generic drug development involves a deep understanding of the scientific principles underlying drug development, including pharmacology, pharmacokinetics, and bioequivalence. Bioequivalence Studies : Bioequivalence studies are a critical component of generic drug development.

Generic Drugs 98

Generic Drugs Bioequivalency Development Drugs 98

Pharmaceutical Technology

FEBRUARY 23, 2023

Quotient Sciences helps biotech and pharma customers in the development and optimization of drug products. Our chemists and formulation scientists review the properties of new drug candidates and “work their magic” to develop formulations that improve the exposure profile of the compound.

Development 246

Development Drugs Bioavailability In-Vivo 246

Pharmaceutical Technology

OCTOBER 28, 2022

According to Dr Mansoor Amiji of Northeastern University: “Instead of relying on product quality as a readout after the product is made, you start to implement these procedures into the product production processes. Practising QbD in biosimilar product development.

Bioequivalency 130

Bioequivalency Production Contamination Branding 130

Worldwide Clinical Trials

MAY 30, 2024

was withdrawn, rendering it unapproved for patient use, based on negative review comments by the Committee for Medicinal Products for Human Use. Indeed, there is a continuing trend towards combination products where treatments can target multiple complementary points within disease pathology. The MAA file in the E.U.

Gene 204

Gene Clinical Trials Clinical Trials Gene Therapy 204