By Rick Ng

A complete advisor to the advanced and long method during which a drug arrives out there. the method has parts of clinical study, scientific ethics, company, and law; statistics exhibit that out of 5,000 compounds with preliminary promise, 5 will move into human scientific trials and one turns into an authorized drug. The reference lists present FDA and eu instructions and covers regulatory gurus and tactics in Japan and China. Of curiosity to pros within the pharmaceutical in addition to scholars of pharmacy, medication, or existence sciences and others drawn to drug discovery. Ng is supervisor of regulatory affairs for the Biopharmaceutical production know-how Centre, Singapore"

Show description

Read Online or Download Drugs: From Discovery to Approval PDF

Best pharmacy books

Free Energy Calculations in Rational Drug Design

Unfastened power calculations signify the main actual computational procedure on hand for predicting enzyme inhibitor binding affinities. Advances in machine energy within the Nineties enabled the sensible program of those calculations in motive drug layout. This e-book represents the 1st accomplished evaluate of this turning out to be zone of study and covers the elemental idea underlying the strategy, a variety of cutting-edge thoughts designed to enhance throughput and dozen examples in which unfastened power calculations have been used to layout and overview power drug applicants.

The School of Pharmacy, University of London. Medicines, Science and Society, 1842–2012

The varsity of Pharmacy, college of London: medications, technological know-how and Society, 1842-2012 represents the wealthy historical past of the college of London university of Pharmacy via a number of colour images, very important advances within the pharmacy occupation, cultural milestones, biographies and extra. Written in an attractive and authoritative type, this booklet depicts the chronological background of the varsity from its institution in 1842 to the current day with a nod towards its aspirations for the long run.

Venom Genomics and Proteomics

This quantity offers the reader with fresh advances within the fields of molecular toxinology, the biotechnological purposes of venom pollutants, and antivenom creation. The content material of the twenty chapters of Venom Genomics and Proteomics illustrates not just the big development made because the implementation of omics applied sciences within the box of toxinology, yet one additionally realizes the line nonetheless forward to arrive a holistic view of venomous platforms.

Pharmaceutical Process Scale-Up

Concentrating on clinical and functional facets of procedure scale-up, this source information the speculation and perform of moving pharmaceutical strategies from laboratory scale to the pilot plant and construction scale. It covers parenteral and nonparenterel beverages and semi-solids, items derived from biotechnology, dry mixing and powder dealing with, granulation and drying, fluid mattress functions, compaction and tableting, and picture coating and regulatory specifications for scale-up and postapproval alterations.

Extra info for Drugs: From Discovery to Approval

Example text

2 The p53 Protein in Cancer The p53 gene is a tumor suppressor gene, which means that its activity stops the formation of tumors via the production of p53 protein. As shown in the picture below, the p53 protein has four identical chains, which are joined together by a central tetramerization domain. The p53 protein molecule wraps around and binds DNA. This wrapping action then turns on another gene, which codes for a 21-kDa protein that regulates DNA synthesis. Normally, a cell grows by cell division and then dies through a process called apoptosis—programmed cell death.

Drugs can interact with enzymes to modulate their enzymatic activities. Intracellular Receptors: These receptors are in the cytoplasm or nucleus. Drugs or endogenous ligand molecules have to pass through the cell membrane (a lipid bilayer) to interact with these receptors. The molecules must be hydrophobic or coupled to a hydrophobic carrier to cross the cell membrane. Cell Surface Receptors: These receptors are on the cell surface and have an affinity for hydrophilic binding molecules. Signals are transduced from external stimuli to the cytoplasm and affect cellular pathways via these surface receptors.

The common feature of this superfamily (there are many different families and subtypes of receptors in this group) of receptors is that there are seven domains that cross the cell membrane (Fig. 6). These seven transmembrane receptors are often referred to as serpentine receptors. The serpentine receptors are coupled to the G-proteins (guanine nucleotide regulatory proteins) inside the cell. There are three subunits that make up the G-proteins: α, β, and γ. When a ligand, for example, a drug or neurotransmitter, binds to the receptor on the cell surface, the shape of the receptor changes.

Download PDF sample

Rated 4.99 of 5 – based on 41 votes