Glossary

Division of Toxicology (CFSAN)

Used in Clinical Trials, this is a method to ensure that any one party cannot improperly influence the test. The product (either in a single strength dosage or in multiple dosages) and the placebo are packaged and given a code name known only to the initiating party. These are then sent to another party who gives the coded packages yet another code name or number, and makes a matrix of the previous name/number to the new name/number. This is then sent to the physician who administers these to the patient. At the end of the test, the physician provides records of which patient received which code name/number product. This is then cross-referenced to the intermediate matrix to determine the original code name/number. The results of the treatment are then correlated to determine the efficacy of the drug.

The structure of DNA as proposed by Watson and Crick. It consists of two right-handed helical polynucleotide chains coiled around the same axis. The two chains are anti-parallel with their 3rd. to 5th internucleotide phosphodiester bonds running in opposite directions. Under most conditions, the coiling of the chains is such that if the ends are held still, as in circular DNA or in a large chromosome, the chains cannot be separated except by cleavage of one of the strands.

A study design in which neither the investigators nor the subjects know the treatment group assignments of individual subjects.

A clinical trial design in which neither the participant individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo (or another therapy). Double-blind trials are thought to produce objective results , since the expectations of the doctor and the participant about the experimental drug do not affect the outcome; also called double-masked study.

A study design that is utilized when two different looking products are being tested against each other. A Placebo to Match (PTM) is made for each of the different products. the patients then take either the active of one product and PTM the other or viceversa. For example, if product X and product Y look different, a double dummy design would call for patient 1 to take product X and PTM product Y and patient 2 to take product Y and PTM product X.

Engineering Control that uses airflow to entrain dust emissions and capture them onto a filter. Also referred as Laminar Air Flow (LAF).

That part of an automatic orbital weld sequence during which the welding current is gradually reduced prior to extinguishing of the welding arc. The downslope portion of a welded joint is seen as a tapering of the end of the weld bead with a reduction of penetration from the beginning to the end of the downslope so that the final weld bead is small with minimal penetration.

In chemical engineering, those phases of a manufacturing process that follow the biotransformation stage. Usually refers to the recovery and purification of the product of a fermentation process.

In molecular biology, the stretch of nucleotides of DNA that lie in the 3’ direction from the site of initiation of transcription, which is designated as +1 (remembering the convention that the sequence of a DNA molecule is written from the 5’ end to the 3’ end). Downstream nucleotides are marked with plus signs, e.g., +2, +10. Also, to the 3’ side of a particular gene or sequence of nucleotides.

A general term for all the things which happen in a biotechnological process after the biology, be it fermentation of a micro-organism or growth of a plant. It is particularly relevant to fermentation processes, which produce a large quantity of a dilute mixture of substances, products and micro-organisms. These must be separated, and the product must be concentrated and purified, and converted into a form which is useful.

Drug Product

Differential Pressure

Division of Physics (CDRH)

Division of Planning (NCTR)

Division of Pharmaceutical Analysis (CDER)

Division of Public Affairs (CDER)

Division of Pre-marketing Assessment III and Manufacturing Science (CDER)

Division of Pulmonary and Allergy Products (CDER)

Discrete-Particle Counter

Drug Price Competition and Patent Trade Restoration Act of 1984

N,N Diethyl-1,4,Phenylenediamine Sulfate

Division of Production Drugs (CVM)

Division of Portfolio Development (OC)

Division of Pediatric Drug Development (CDER)