Directory of Approved Biopharmaceutical Products (Pharmaceutical Science S)

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Careers in Pharmacy What is Clinical Pharmacy? What is Medicinal Chemistry? What is Pharmaceutical Sciences? Why PharmD at Michigan? Established in , the College of Pharmacy became the first pharmacy school in a public university. Career Connections Student Handbook. Submit Personal News. Pharmaceutical Sciences Intro to Drug Development Credits: 2 This is an introductory course for undergraduates, primarily freshman and sophomore level students, who are interested in various aspects of the science behind the drug development process.

This course will cover the process of drug discovery and development, introduction to different aspects of basic and applied sciences involved in drug candidate identifications, and how candidate molecules are made into drugs and drug products in the clinic and market. Pharmaceutical Sciences Molecules to Drugs to Drug Products II Credits: 1 This course provides in depth content covering many aspects of the science and engineering of pharmaceutical durg discovery, development, and manufacturing.

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Pharmaceutical sciences must have been taken previously or concurrently. Pharmaceutical Sciences Biopharmaceutics and Biology of Drug Delivery Credits: 3 This course serves as an introduction to pharmaceutical sciences. It will cover biological and physico-chemical components related to pharmaceutical sciences, drug delivery, drug molecule movement in the body, and drug product performance and development, including biopharmaceutics and pharmacokinetics.

Instructor: Staff Terms: Fall. Pharmaceutical Sciences Physical Chemistry of Drug Products Credits: 3 Students will be taught basic concepts of Physcial Chemistry including solubility, stability, mass transfer, chemical kinetics and their application to the design of pharmaceutical dosage forms like tablets, injectable solutions, emulsions, cream and adhesive patches.

Drugs and the Pharmaceutical Sciences - Routledge

Application of basic pharmaceutics principles to the design of nanoparticle products, recombinant proteins and drug delivery approaches will be covered. Pharmaceutical Sciences Undergraduate Seminar PharmSci Credits: 1 Students will be exposed to the wide range of contemporary research in pharmaceutical sciences, medicinal chemistry and clinical pharmacy. Presenters will be University of Michigan or invited scientists and graduate students primarily from the College of Pharmacy.

Students are permitted to attend seminars from any of the three seminar programs offered by the College of Pharmacy. Pharmaceutical Sciences Medicinal Cannabis Credits: 2 This course will cover all aspects related to the medicinal use of Cannabis, focusing on different perspectives offered by lecturers with highly relevant, related expertise.

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Lecturers will include local scientists and physicians, Medical Cannabis doctors, dispensary owners, Cannabis lawyers, politicians, and students who are pursuing Cannabis-related careers. Instructor: Staff Terms: Winter. Students may work on a single project or be exposed to several types of projects during the course. For specific details of the course, students should contact individual faculty. Pharmaceutical Sciences Drug Delivery and Solutions Credits: 3 Basic principles of drug delivery are developed with respect to identifying and characterizing biological and physical-chemical barriers to the bioavailability of drugs.

Routes of drug delivery and related dosage forms are also introduced.

Specific emphasis is placed on building principles and solving problems in equilibria, transport, and chemical kinetics of drug solutions as they relate to liquid dosage form performance. Pharmaceutical Sciences Drug Delivery and Drugs in Dispersed Systems and Solid Forms Credits: 3 Course content includes the formulation, development and approval process of dosage forms comprised of dispersed phases suspensions and emulsions and solid phases amorphous and crystalline.

The course integrates physicochemical and concepts with quality and performance of topical, oral and inhalation dosage forms. Topics include process engineering in the drug discovery, high throughput characterization and optimization of new chemical entities, solid-state engineering, and intelligent pharmaceutical manufacturing systems. Lectures, problems, and Internet and library study will be used to develop the ideas presented. Prerequisites: Senior or graduate standing, permission of instructor. Instructor: Amidon Terms: Winter.

Pharmaceutical Sciences Investigations in Pharmaceutics Credits: Original investigation of a laboratory or library problem to be selected after consultation with the instructor. A paper is required.

Prerequisites: PharmD students. Permission of instructor. Pharmaceutical Sciences Pharmacokinetic Concepts and Applications Credits: 4 This course is the third of four required courses in the pharmaceutical sciences curriculum. Course content includes the absorption, distribution, metabolism, and excretion of drugs and drug-related species by the body. Additional emphasis is placed on designing suitable dosage regimens for the treatment and prevention of disease in humans.

Three lecture hours and one discussion hour a week. This entry level course is designed for 1st or 2nd year graduate students in the pharmaceutical or related biomedical sciences. Instructor: Smith Terms: Fall. This course focuses on the physical chemistry of drugs and drug delivery systems. Thermodynamic principles, solution and interfacial phenomena, solubility, and solid state properties will be emphasized with a focus primarily on small molecules.

The resulting controller action is implemented in the process through suitable actuators. Process data are stored in a comprehensive database for quality assurance and regulatory purposes. In order to conform to quality requirements and regulatory demands, both data collection and structure of the associated knowledge management system are critical for an automated control system. With that regard, newly arising issues, such as traceability of the pharmaceutical product throughout the continuous process stream and storing processed data rather than raw data e.

The centerpiece of the control system is the controller structure that initiates corrective actions based on the provided measurement information. It constantly calculates the difference between the variable that has to be controlled and a specified set point value i. This error is then processed and forwarded to an actuator that manipulates a correlated process variable manipulated variable accordingly.

However, rise and settling time, as well as oscillations around the desired set point, can significantly be reduced and adjusted according to specific process requirements by accurate tuning of the controller parameter and appropriate expertise in the controller design. The deviation between the controlled variable and the specified set point is used to trigger and actuator action, adjusting the associated manipulated variable and compensating for the occurring disturbances.

Controllers of this type require excellent knowledge of the controlled system and all occurring disturbances so that adequate actuator actions are performed to keep the controlled variable within its acceptable limits. Cascade controllers combine two or more controllers in master and slave loops to serve control variables that interact on various time scales, e. Proportional P , differential D , and integral I control terms and combinations thereof are the simplest and most commonly used controller types for determining the control action of the manipulated variable.

PID control is considered to be the best option for a general process with unknown dynamics and optimal for serving fast control loops. Unlike PID control, fuzzy controllers evaluate physical input signals with linguistic terms gained from human expert knowledge via logic of operations. In industries, in which automated process control is an inherent part of process development, advanced controller approaches, such as MPC, have been applied for many years.

The pharmaceutical industry is beginning to introduce such methods as well. It calculates future actuator values using a dynamic presses model either mechanistic or stochastic and past and current measurements. It is achieved by solving a minimization problem of a defined objective function fulfilling all given process constraints. A distinguishing feature of MPC is that even though the control horizon comprises several actuator steps, only the first control action is effectively implemented.

For the next action, future values of the new control horizon are recalculated and, again, only the first control action is implemented. Schematic structure of a MPC approach adapted from Ref. Past measurements of control variables and prior implemented actuator values are used to predict the future behavior of the system.

Most current publications propose simple and common proportional—integral —derivative [PI D ] control systems for pharmaceutical production plants. An interesting method was proposed by Rolandi and Romagnoli in and A combination of scheduling and control via MPC was reported recently. In the end, the choice of a control structure depends on the specifics of the process and a consideration of all control expectations and requirements.

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Regeneron Pharmaceuticals - Wikipedia

In some cases, a combined approach may be most suitable. Such combined structures can vary from simple cascaded PI D controllers, serving faster and slower control loops and interacting process variables at a time, , to novel MPC—PID hybrid approaches where MPC represents a supervisory control layer that delivers the set points for faster acting regulatory PID loops. Furthermore, it depends on accurate, multivariable, and linearized models of the process that might not always be available.

It provides a pragmatic industry guidance to understanding and risk management of computerized systems in GxP environments, ensuring the identification, analysis, evaluation, and control of associated risks. Regulatory authorities play an important role in promoting automated CM. Moreover, appropriate training of technical staff should to be encouraged, and a larger number of joint projects of industry and academia are required to reduce regulatory risks and attain regulatory clarity for industry.

This task is not impossible. Reconsidering obsolete process development approaches and regulatory demands are critical for its success. Advanced automated process control is a critical issue for automated CM and more research in this field is required. Future products are more complex. Thus, new production technologies will augment classical routes more and more. Especially the last issue should not be underestimated. Personalized and individualized medicines, including drug products for specific patient populations e. Process engineers will have to provide solutions for future individualized demands.

Making Biologic Medicines for Patients: The Principles of Biopharmaceutical Manufacturing

In the following sections, we provide an overview of current and future trends.