PSTT Vol. 1, No.
4 July 1998
Artificial intelligence in
pharmaceutical product formulation:
knowledge-based and expert systems
Raymond C. Rowe and Ronald J. Roberts
The pharmaceutical formulation process is a highly specialized task
requiring specific domain knowledge and often years of experience.
Knowledge-based systems, expert systems, neural computing and
machine-learning derived from research into artificial intelligence
can assist the efficient formulation of products and therefore increase
productivity, consistency and quality. The authors provide an introduc-
tion to the technology of knowledge-based and expert systems.
▼ In all cases of product formulation – whether
Raymond C. Rowe* and
Ronald J. Roberts
it be for tablets, capsules, parenterals or any one
Zeneca Pharmaceuticals of the numerous other dosage forms – in generic
Alderley Park terms the process is the same, beginning with
Macclesfield the presentation of some form of product speci-
UK SK10 2NA fication and ending with the generation of one
*tel: ⫹44 1625 513112
or more formulations that will fulfil the require-
fax: ⫹44 1625 512381
e-mail: ments. In many cases the specification has poten-
Ray.Rowe@alderley.zeneca.com tially conflicting requirements and thus it is left
to the highly skilled and experienced formulator
to balance these and produce the optimum com-
promise formulation.
It is not surprising, therefore, that product
formulation has become a popular target for the
development of expert systems due to the poten-
tial pay off of a system that can create formu-
lations with little or no human intervention.
Technology
There is a wide range of views of what defines
an expert system. Examples of widely used defi-
nitions include:
• ‘An expert system is a knowledge-based sys-
tem that emulates expert thought to solve sig-
nificant problems in a particular domain of
expertise’1
Copyright ©1998 Elsevier Science Ltd. All rights reserved. 1461-5347/98/$19.00. PII: S1461-5347(98)00042-X
research focus reviews
• ‘An expert system is a computer program that
draws upon the knowledge of human experts
captured in a knowledge base to solve prob-
lems that normally require human expertise’2
Because of their emphasis on knowledge, the
terms ‘expert system’ and ‘knowledge-based sys-
tems’ are often used interchangeably. If any dif-
ference does exist, it is in how their input knowl-
edge is acquired. In expert systems input
knowledge is acquired, in the main, from human
experts, whereas in knowledge-based systems it
is usual for input knowledge to be acquired
through non-human interaction, such as through
information systems and databases.
In their simplest form, both systems have three
major components: an interface, monitor and
keyboard allowing two-way communication be-
tween the user and the system; a knowledge base
in which all the knowledge pertaining to the do-
main is stored; and an inference engine in which
the knowledge is extracted and manipulated to
solve the relevant problem. Inferencing strategies
may be either forward chaining, which involves
the system reasoning from data and information
obtained by consultation with the user to form a
hypothesis, or backward chaining, which in-
volves the system starting with a hypothesis and
then attempting to find data and information to
prove or disprove the hypothesis. Both strategies
are included in most expert systems.
Knowledge in any domain takes the form of
facts and heuristics; the former being valid, true
and justifiable by rigorous argument, the latter
(often referred to as ‘rules of thumb’) being the
expert’s best judgement in any particular circum-
stance and hence justifiable only by example.
Associated with these are the terms ‘data’ and
153
reviews research focus
Box 1. Levels and categories of knowledge
• Shallow – Surface-level, specific, heuristic
• Deep – Complete, integrated, conceptual
• Explicit – Conscious, able to be articulated
• Tacit – Implicit in expert’s ability to solve problems
• Declarative – Descriptive representation of facts
• Procedural – Detailed set of rules
• Meta – Knowledge about knowledge
‘information’, the former referring to facts and figures, the lat-
ter being data transferred by processing such that it is mean-
ingful to the recipient. Knowledge can therefore be regarded as
information combined with heuristics and rules. There are
many levels and categories of knowledge (Box 1) and it is the
objective of the knowledge engineer to acquire or elicit this
knowledge and organize it into a computer-readable format.
Knowledge acquisition is probably one of the most difficult
stages in the development of an expert system. It is both time
consuming and tedious as well as being expensive and often
difficult to manage. However, it is a necessary element in the
building of an expert system and, if done well, will undoubt-
edly lead to systems of potential use.The basic model of knowl-
edge acquisition is one of a team process whereby the knowl-
edge engineer mediates between the expert(s), the users and
the knowledge bases.The knowledge engineer must acquire or
elicit knowledge from not only the expert(s) but also all the
other potential sources; these include written documents (re-
search reports, reference manuals, operating procedures policy
statements) and consultants, users and managers. In the case of
experts, in the main knowledge is acquired through face-to-
face interviews. This process is tedious and can place great de-
mands on both the expert and knowledge engineer but re-
quires little equipment (e.g. tape recorder or note book), is
highly flexible and often yields a considerable amount of use-
ful information. At all times, there must be an empathy be-
tween the participants and, in many cases, it is helpful to have
two knowledge engineers present at the interview.
Box 2. Methods of knowledge representation
• Production rules
• Frames
• Semantic networks
• Decision tables
• Decision trees
• Objects
154
PSTT Vol. 1, No. 4 July 1998
A technique that is often used in the acquisition process is
the rapid prototyping approach. In this approach, the knowl-
edge engineer builds a small prototype system as early as
possible and this is shown to both the expert and user, who can
then suggest modification and additions.This system grows in-
crementally as more information and knowledge is gained, and
this methodology has been used successfully in the develop-
ment of systems for pharmaceutical formulation.
Once acquired, there are many ways of representing the
knowledge in the knowledge base (Box 2). It is probable that
the most common methodology is the production rule; this ex-
presses the relationship between several pieces of information
by way of conditioned statements which specify sections under
certain sets of conditions.
• IF (Condition 1)
• AND (Condition 2)
• OR (Condition 3)
• THEN (Action)
• UNLESS (Exception)
• BECAUSE (Reason)
Each rule implements an autonomous piece of knowledge
and is easy to understand. Unfortunately, complex knowledge
can require large numbers of rules, causing the system to be-
come difficult to manage. The decision over which method of
knowledge representation should be adopted is dependent pri-
marily on the complexity of the domain. In a survey of 50 ex-
pert systems in the UK in 1987/1988, it was found that, al-
though over half the systems were developed using production
rules, nearly a sixth used multiple approaches3.
Expert systems can be developed using either conventional
computer languages, special purpose languages or with the as-
sistance of development shells or toolkits. Conventional lan-
guages such as PASCAL and C have the advantages of wide
applicability and full flexibility to create the control and infer-
encing strategies required. They are also well supported and
easy to customize. However, considerable amounts of time and
effort are needed to create the basic facilities.
Specialized languages such as LISP (a recursive language and
the primary one for artificial intelligence research), PROLOG (a
language based on first order predicate logic) and SMALLTALK
(an object-orientated language) have been used extensively in
the development of expert systems because they share the ad-
vantages of applicability and flexibility of the conventional
languages but are also faster to implement.
Expert system shells and toolkits are sets of computer pro-
grams written in either conventional or specialized languages
that can form an expert system when loaded with the relevant
knowledge. They compromise on applicability and flexibility
PSTT Vol. 1, No. 4 July 1998
Table 1. Published applications of pharmaceutical product
formulation expert system
Company/Institution Domain Development tool
Cadila Laboratories (India) Tablets PROLOG
University of Heidelberg Aerosols C/SMALLTALK
Tablets
Capsules
IV injections
University of London/Capsugal Capsules C
Sanofi Research Capsules PFES
Zeneca Pharmaceuticals Tablets PFES
Parenterals
Film coatings
Boots Company Topicals PFES
but allow more rapid development. Many offer basic facilities
such as the means to prepare and store knowledge as a set of
rules and to make deductions by chaining the rules together in
an inferential process.
Shells differ in their secondary characteristics, such as user
interfaces, operating speeds, the method of knowledge represen-
tation and the associated algorithmic and arithmetic computa-
tional facilities. One such shell of specific importance in product
formulation is Logica’s Product Formulation Expert System
(PFES, Logica UK Ltd), a reusable software kernel and associated
methodology developed from underlying research and con-
ducted by a consortium of Shell Research, Schering Agrochemi-
cals, and Logica UK, under the UK Alvey Programme sponsored
by the UK Department of Trade and Industry between 1985 and
1987. PFES was designed specifically for building formulation
expert systems. Its capability is generic, providing knowledge
representations common to most product formulation tasks and
thus allowing new applications to be developed rapidly and ef-
fectively. It provides a decision support framework consisting of
two levels: a task level that contains the distant problem-solving
steps involved in creating a formulation, and a physical level
that contains specific knowledge about the properties of the
ingredients and processes involved4,5.
The choice of development method used depends, inter alia,
on the domain, the type of knowledge to be encoded, the hard-
ware platform and the end-user environment. In 1991, a survey
of expert systems showed a distribution of methods of 11%
conventional languages, 23% specialized languages and 66%
shells and toolkits6. All the methods have been used for phar-
maceutical product formulation (Table 1).
Applications
The first recorded reference to the use of expert systems in
pharmaceutical product formulation was by Bradshaw on
research focus reviews
27 April 1989 in the London Financial Times7; this was followed
closely by an article in the autumn of the same year by Walko8.
Both refer to the work then being undertaken by personnel at
ICI (now Zeneca) Pharmaceuticals UK and Logica UK, to de-
velop an expert system for formulating pharmaceuticals using
PFES. Since that time, several companies and academic institu-
tions have reported their experiences in this area (Table 1). It
should be noted that those systems listed have been described
in the open literature; other companies/institutions have de-
veloped systems for similar domains but many have been
reticent to report their experiences.
Cadila System
This system was developed by personnel at Cadila Laboratories
(Ahmedabad, India) and has been designed to formulate
tablets for active drugs based on their physical (e.g. solubility,
hydroscopicity), chemical (e.g. functional groups) and bio-
logically inter-related (e.g. dissolution rate) properties9. The
system first identifies the desirable properties for optimum
compatibility with the drug, selects those excipients that have
the required properties and then recommends proportions
based on the assumption that all tablet formulations comprise
at least one binder, one disintegrant and one lubricant. Other
excipients such as fillers or glidants are then added as required.
Knowledge acquired through active collaboration with ex-
pert formulations is structured as decision tables with derived
production rules. The system written in PROLOG is menu-
driven and interactive with the user who is prompted to enter
all the known properties of the new active drug. When proper-
ties have descriptors (e.g. functional groups, solubility, etc.)
these are displayed for selection by the user. The system then
suggests a formulation with alternatives and explanations (if
required). An example formulation for a dose of 500 mg of
paracetamol is shown in Table 2. The filler is unnamed, but it
can be assumed that it will not be lactose because the relevant
production rule indicates that there would be an interaction
between it and the secondary amine group on the drug.
The prototype system, when first implemented, had 150 rules
but this has rapidly expanded to over 300 rules to increase reli-
ability. It took 6–7 months to develop and is reported to have re-
duced the development time for a new tablet formulation by 35%.
Table 2. An example of a tablet formulation for paracetamol
as generated by the Cadila System
Paracetamol 500.0 mg
Unnamed filler 20.0 mg
Pre-gelatinized starch 43.7 mg
Sodium starch glycolate 5.0 mg
Stearic acid 2.5 mg
155
reviews research focus
Galenical Development System, Heidelberg
This system, developed by personnel in the Departments of
Pharmaceutics and Biopharmaceuticals and of Medical
Informatics at the University of Heidelberg (Germany), has
been designed to provide assistance in the development of a
range of formulations (e.g. aerosols, tablets, capsules, intra-
venous injections), starting from the chemical and physical
properties of an active drug. The project was initiated in
199010 and extensively revised and enhanced in the in-
terim11,12. Originally implemented in C, the system has re-
cently been upgraded using SMALLTALK. Knowledge represen-
tation is by means of objects, frames and production rules.
Because of the complexity of the overall process, the devel-
opers have adopted an approach whereby the system focuses on
one problem and its associated subset of specification and con-
straints at a time. These distinct development steps are worked
through in succession, care being taken that any solution
should not violate any constraints from previous steps.
The output of the system is a formulation together with pro-
duction method, recommended packaging and, where appro-
priate, predicted product properties. Explanation of the strategy
used, formulae and rules fired as well as text and literature ref-
erences can be produced on request. An example formulation
for a 150 mg dose of griseofulvin in a hard gelatin capsule is
shown in Table 312.The system was introduced for field trials in
December 1996.
University of London/Capsugel System
This system, developed by personnel at the School of Pharmacy,
University of London (UK), supported by Capsugel together
with personnel from the Universities of Kyoto (Japan) and
Maryland (USA) has been designed to aid the formulation of
hard gelatin capsules13.The system, implemented in C, uses de-
cision trees and production rules for knowledge representation.
The system is fully interactive with the user and has a ques-
tionnaire to assist in collecting all necessary input data. From
these data the system uses a variety of methods to predict prop-
erties of mixtures of the new drug and various excipients and
recommends a formulation with any necessary powder pro-
cessing and filling conditions. In addition, the system provides
Table 3. An example of a capsule formulation for
griseofulvin as generated by the Galenic Development
System, Heidelberg, Germany
Griseofulvin 150.0 mg
Microcrystalline cellulose (PH102) 199.2 mg
Magnesium stearate 3.5 mg
Capsule size No. 1
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PSTT Vol. 1, No. 4 July 1998
a statistical design to optimize the formulation quantitatively,
the specification of the excipients used, recommended tests to
validate the formulation and a complete documentation of the
decision process.
The system is unique in that its knowledge base is broad; it
contains information on a large number of excipients; a data-
base of marketed formulations from Germany, Italy, Belgium,
France and the USA; a database on literature references associ-
ated with the formulation of hard gelatin capsules; experience
and non-proprietary knowledge from a group of international
experts; and the results from statistically designed experiments
on capsule formulation. The data is frequently updated and the
system has a semi-automatic learning tool that monitors users’
habits regarding the use of excipients. These, together with the
results from user questionnaires, are analysed by the expert
system founder group providing the background to further
enhancements.
Sanofi System
This system, developed by personnel at the Sanofi Research
Division, has been designed to formulate hard gelatin capsules
based on specific preformulation data on the active drug14.
The system, implemented using PFES, generates one first-pass
capsule formulation with as many subsequent formulations as
desired to accommodate an experimental design. Knowledge
acquisition was by interview and structured using objects,
frames and production rules.
The user is first prompted to enter specified preformulation
data on the active drug and the system recommends a formu-
lation with relevant capsule size and production information.
An explanation log, providing details of the decisions and rea-
soning used by the system, are also recorded. An example of a
formulation of 100 mg of naproxen is shown in Table 4.
Table 4. An example of a capsule formulation for naproxen
as generated by the Sanofi System
Naproxen 100 mg
Lactose (hydrous) 224 mg
Microcrystalline cellulose (PH105) 060 mg
Sodium lauryl sulphate 004 mg
Talc 012 mg
Capsule size No. 0
Zeneca systems
Since April 1988, three systems have been developed by person-
nel at Zeneca Pharmaceuticals15–17. These systems, designed for
formulating tablets, parenterals and film coatings, respectively,
have all been implemented using PFES. Each was developed using
PSTT Vol. 1, No. 4 July 1998 research focus reviews

relatively high investments of time and resources are often

Table 5. Example of tablet formulation for a model drug as
generated by the Zeneca System18 needed for their development, it is imperative to identify and
objectively assess their benefits. In a large survey in 1989 in-
Drug A 50.0 mg 150.0 mg volving nearly 450 responses from a wide variety of organiza-
Lactose monohydrate 166.9 mg – tions and types of users, several key benefits were identified20.
Dicalcium phosphate dihydrate – 165.7 mg Overall, the most important benefits were those concerned
Croscarmellose sodium 4.8 mg 7.0 mg with the accuracy of the decision making, improved problem
Polyvinyl pyrrolidone 4.8 mg –
solving and quality/accuracy of work (Fig. 1).The least impor-
Hydroxypropyl methylcellulose – 7.0 mg
tant benefits were those concerned with the reduction in staff
Sodium lauryl sulphate 0.7 mg 1.1 mg
Magnesium stearate 2.4 mg 3.5 mg
numbers or using less skilled staff.
Thomas21 has attempted to capture the overall business im-
Tablet diameter 8.0 mm 10.0 mm pact of expert studies in terms of quality availability and consist-
ency of expertise available. Expert systems should enable man-
agers to begin to manage expertise as a corporate asset leading
two experts, one with extensive heuristic knowledge, the other to an increased competitive edge, improved risk management,
with extensive research knowledge, and structured using objects, increased revenue, decreased costs and increased profitability.
frames and production rules by specialized consultancy support. Such is the overall picture of the benefits of developing an
Each system is fully interactive with the user, requiring expert system. It is more pertinent to discuss those found by
specified input data on the active drug. The systems then rec- the users of systems in pharmaceutical formulation.
ommend formulations with predicted properties (e.g. com-
paction properties for tablets, tonicity and storage life for par- Knowledge availability and protection
enterals, opacity and cracking potential for film coatings). Each The developers of the University of London/Capsugel System
system contains ‘Help’ routines providing both on-line help in have reported the benefit of being able to use knowledge from a
the use of the system and the rationale behind the adoption of broad base13. Others9,14 have reported the benefit of the prompt
the specified rules/formulae used. The user is able to browse availability of information and the rapid access to physical and
the knowledge trees at will but is unable to edit them without chemical data of both drugs and excipients reducing the time
privileged access. Explanations for any recommendations made spent searching literature. Rowe15 has reported the existence of a
by the systems can be accessed easily if required. The tablet coherent durable knowledge base not affected by staff turnover.
formulation system is the most frequently used expert system
and is now an integrated part of the development strategy in Consistency
this domain. An example of a tablet formulation for a model All systems generated robust formulations with increased cer-
drug recommended by the system is shown in Table 5. tainty and consistency.This was seen as a distinct benefit where
regulatory issues are important.
Boots System
Although not strictly developed for pharmaceutical formu-
lation, this system has been included since it is the only one Accuracy of decision making
known for formulating topicals. Developed in 1990 by person- Improved problem solving

nel at the Boots Company, the system won second prize in Accuracy of work
Quality of work
the UK Department of Trade and Industry Manufacturing
Cost effectiveness
Intelligence Awards in 199119. The system was developed in
Increased output
the first instance to assist in the formulation of sun oils but has
Reduced skill level
been rapidly extended to cover creams and lotions. Knowledge
Reduced skilled staff
was acquired from senior formulators using interviews and
Increased throughput
structured as objects, frames and production rules.
Reduced staffing
Implemented in PFES, this is the only system in which the de-
velopers have given details of costings and quantitative benefits. 0 5 10 15 20 25
Total mentions (%)
Benefits Figure 1. A survey of key benefits for expert systems as reported by
Although there is a great deal of interest in expert systems, Dewar20.
there is still much uncertainty regarding their benefits. As

157
reviews research focus
Training
All systems have been used to provide training for both novices
and experienced formulators. In topical formulation, use of the
expert system has enabled experienced formulators to experi-
ence unfamiliar new excipient combinations19.
Speed of development
Reduction in the duration of the formulation process has been
widely reported9,15,19. It has been reported that formulators
working in the topical domain can now produce a formulation
in 20 minutes that might otherwise have taken two days to
achieve19. A 35% reduction in the total time needed to develop
a new tablet formulation has also been reported9.
Cost savings
Cost savings can be achieved by not only reducing the develop-
ment time but also by the more effective use of materials.
Several users have reported a benefit in being able to plan the
purchase and stocking of excipients and to reduce the size of
raw material inventories9,19.
Freeing experts
The implementation of expert systems in product formulation
has inevitably allowed expert formulators to devote more time
to innovation14,19. In topical formulation it has been reported
that the use of an expert system has released approximately
30 days of formulating time per year per formulation19.
Improved communication
Several users have reported that expert systems promote com-
munication and discussion amongst not only experts but also
managers, enabling them to identify critical areas requiring re-
search and/or rationalization9,14,19.
Of all the systems developed for pharmaceutical formulation
only one of those provided costings and had undertaken a
cost–benefit analysis. Wood19 has reported that the expert sys-
tem developed by the Boots Company cost £25,400 consisting
of £10,400 for hardware and software, £6000 for consultancy
and £9000 for experts’ time.With an estimated annual cost sav-
ing in the region of £200,000 this system delivered a payback
of approximately three months.
Issues
There are several issues that have reduced levels of general im-
plementation of expert systems (Fig. 2). Without the potential
to deliver real business benefit, management cannot be
expected to support resource projects and hence the identifi-
cation of the most suitable application is an essential pre-
requisite. There are many features that indicate possible
158
PSTT Vol. 1, No. 4 July 1998
No budget
No management support
No benefits
No management awareness
No expert
No knowledge engineer
No financial gain
No confidence
Prefer conventional
No technical support
No user
0 5 10 15 20
Mentions (%)
Figure 2. A survey of issues that prevented the implementation of
expert systems as reported by Dewar20.
advantages of expert systems (Box 3), and experience in the
product formulation domain would suggest that these be
adopted as a screening process for assessing the technical
feasibility of an application.
Because the development of an expert system is likely to be
high profile and failure will be very visible, a poor choice of
application can have disastrous consequences, not least in the re-
jection of the technology. Attempting to develop an application
that will solve all problems in the first instance can be just as bad.
It is better to limit the scope of the application at the outset or
sub-divide the domain into small manageable modules and de-
velop each in turn; this has been done in the Galenical Develop-
ment System (Heidelberg, Germany)10–12. Experience has shown
that, in general, the quality of the performance of the developed
system is more important than its scope. However, trivial appli-
cations should not be developed because these can rapidly lose
credibility and support from both experts and management.
Box 3. Features of applications where expert
systems may provide advantages
• Primarily symbolic in nature
• Rule base and heuristics available
• Neither too easy nor too difficult
• Manageable size
• Availability of at least one cooperative and articulate expert
• Non-optimal results tolerable
• Of practical importance
• Part of essential activity
• Occur in a stable environment
• Meet real business need
PSTT Vol. 1, No. 4 July 1998 research focus reviews

Managers have a pivotal role in the development of expert
systems. They do not need to have an in-depth understanding
of the technology but must set the framework within which
the developers work.The management role is crucial to the suc-
cess of the project and, as a result of extensive studies, it is now
known that organizations that are successful in the develop-
ment of expert systems are those whose management play an
active role in coordinating and supporting their initiatives. Ex-
pert systems projects are no different from any other project
and can be planned and managed using common prac-
tices6,22,23.This does not mean that they are well managed. In a
survey of expert systems applications from all UK business sec-
tors, it was found that only 20% of respondents had used any
project planning/management systems20.
An issue that must be managed sensitively at the outset is
that of the role of the expert and users once the system has
been implemented. Although in the surveys (Fig. 1) reduced
staff levels have been seen as one of the least important benefits
of implementation, it can still be an issue with some individ-
uals. It is inevitable that there will be a change in the job de-
scription of both the expert and users and this may or may not
result in a change in the opportunities for career development.
This can result in a lack of cooperation by both users and ex-
perts in both the development and implementation.
Conclusion
Although there are many issues surrounding the development
of expert system applications, the majority of these can be
minimized by good management. The technology is mature
and has proved its ability to generate real business benefit. It
should now be considered routinely as one of the methods for
increasing competitiveness.Within the pharmaceutical product
formulation domain, early scepticism amongst potential users
has, in the main, changed to a mood of enthusiastic partici-
pation. It is unlikely that expert systems will ever replace for-
mulators but as a decision-support tool they are invaluable and
deliver many benefits.
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159