Course: Pharmacotherapy: Understanding Biotechnology Products

Welcome to week 4. This week, we will learn formulation of biotechnology products. First, I am going to give a brief overview and guide to formulation and process development as …

By definition, a complex response model implies the involvement of complex physiologic and regulatory pathways. Logically, the model could be a combination of 2 or more existing models, with biofeedback …

The distinctive characteristics of an indirect response model is that the response is not triggered by an interaction of drug with receptor. Rather, it is elicited via a response mediator, …

The indirect link model stipulates a separate effect site outside the central compartment, and the drug distribution to that compartment causes the delay of effect. On the other hand, the …

Dolly the sheep garnered much attention because she was the first mammal to be cloned from an adult cell. Her successful birth proved that specialized cells could be used to …

Direct link model is the most straight forward if there is no time delay between the plasma concentration and the response. However, this is not the case with most biologics. …

PK/PD modeling has already been used extensively in pre-clinical and clinical drug development. However, few examples exist within the literature on the application of modeling to enable the appropriate engineering …

Repetitive administration of protein-based therapeutics to immunocompetent patients can elicit immune responses in the form of Anti-Drug Antibodies (ADAs). One form of immune response is the activation of B cells, …

This series of slides introduces recombinant DNA technology and the hybridoma monoclonal antibody technology, which contribute to the creation of modern therapeutic treatments for cancer, autoimmune disorders and a host …

Receptor-mediated metabolism is a unique elimination pathway for biologics. It initially entails an interaction of biologics with the membrane receptors on the target structure to elicit pharmacological response. Subsequently, the …

This section lays out the roles, the challenges and the opportunities for the practicing pharmacists within the integrated healthcare system Pharmacists continue to play critical roles in the application of …

This series of slides presents the market, growth, trends, and forecast for biologics and biosimilars for the foreseeable future. Initially, the emergence of biologics as a class was reviewed. Then, …

In general, biologics are metabolized into small peptide fragments or amino acids that are ready for renal excretion or for recycling into protein synthesis. Metabolism happens mainly via intracellular lysosomal …

Compared to small molecule drugs, biologics have unique characteristics in absorption, distribution, metabolism, and elimination. Pharmacokinetics of a biologics is typically characterized by a two-compartment model, with three key parameters, …

The series of biotechnological discoveries witnessed in the early 21st century point to an ever illuminating future for research scientists in the biomedical and agricultural frontiers Recount of several important …