as to the method of production, efficacy, safety and quality of the product. To
obtain a product licence the pharmaceutical company is required to submit a
comprehensive dossier that contains the relevant pharmacological, formulation
and toxicological data and full details of all aspects of the production processes
and dosage forms. The issuing of a product licence gives the pharmaceutical
company or the person ordering its production the right, sometimes subject to
conditions, to produce and sell the new product in the issuing country. Licences
may be revoked if the producer does not strictly keep to the conditions laid
down in the licence. Any changes, at a later date, to the production process,
dosage forms or indications (usage) must also be approved and it is the responsi-
bility of the company to carry out any additional tests that are required.
11.9 Questions
(1) (a) What is the critical path in drug development? (b) List the main stages in
the critical path of the development of a drug.(2) Explain the meaning of the terms (a) dosage form, (b) ELF, (c) telescoping in
drug production, (d) excipient and (e) double blind trial.(3) Outline the chemical factors that need to be considered when scaling up a
research synthesis to pilot plant scale.(4) Outline a possible production scale route for the preparation of the throm-
boxane analogue A.OO
MeCOOHHOMe(5) Explain the differences between (a) preclinical and clinical trials and (b) Phase
I and Phase II trials.(6) What is a patent? Why is it necessary to patent drugs?
238 DRUG DEVELOPMENT AND PRODUCTION